System, Imaging, Pulsed Doppler, Ultrasonic
A pulsed Doppler ultrasonic imaging system is used to visualize blood flow and soft tissue structures in real time, enabling non-invasive assessment of cardiovascular and other anatomical conditions. It is classified as FDA Class 2, reflecting moderate risk and a requirement for 510(k) premarket clearance. The product code is IYN, regulated under 21 CFR 892.1550, within the Radiology medical specialty. This device is eligible for third-party review.
Basic Information
- Product Code
- IYN
- Device Class
- FDA class 2
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1118 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251830 | Sonosite LX Ultrasound System | Jul 10, 2025 | Substantially Equivalent | FUJIFILM Sonosite, Inc. |
| K251169 | Vivid Pioneer | Jul 10, 2025 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K250886 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Jun 18, 2025 | Substantially Equivalent | Philips Ultrasound LLC |
| K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70) | Jun 18, 2025 | Substantially Equivalent | Esaote S.p.A. |
| K250024 | TE Air Diagnostic Ultrasound System | May 30, 2025 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
| K250543 | Voluson Performance 16; Voluson Performance 18 | May 29, 2025 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary care Diagnostics |
| K242594 | DEEPECHO | May 23, 2025 | Substantially Equivalent | DeepEcho |
| K243793 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | May 21, 2025 | Substantially Equivalent | Philips Ultrasound LLC |
| K250020 | Diagnostic Ultrasound System (Recho R9W); Diagnostic Ultrasound System (Recho R9); Diagnostic Ultrasound System (Recho R9 Pro); Diagnostic Ultrasound System (Recho R9 Exp); Diagnostic Ultrasound System (Recho R9S); Diagnostic Ultrasound System (Recho R9T); Diagnostic Ultrasound System (Crius R9 CV); Diagnostic Ultrasound System (Anesus R9 CV); Diagnostic Ultrasound System (Recho R9 Super); Diagnostic Ultrasound System (Recho R9 Lumi); Diagnostic Ultrasound System (Recho R CV); Diagnost | May 19, 2025 | Substantially Equivalent | Shenzhen Mindray Bio-medical Electronics Co., Ltd. |
| K250110 | Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6); | May 16, 2025 | Substantially Equivalent | Shenzhen Mindray Bio-medical Electronics Co., LTD. |
| K241671 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) | May 16, 2025 | Substantially Equivalent | Esaote S.p.A. |
| K242519 | Lumify Diagnostic Ultrasound System | May 15, 2025 | Substantially Equivalent | Philips Ultrasound |
| K242808 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 | May 13, 2025 | Substantially Equivalent | Canon Medical Systems Corporation |
| K243226 | Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) | May 08, 2025 | Substantially Equivalent | Leltek Inc. |
| K242670 | Lumify Diagnostic Ultrasound System | May 08, 2025 | Substantially Equivalent | Philips Ultrasound |
| K250087 | Vscan Air | May 01, 2025 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K250030 | Flash Ultrasound System 5100 Point of Care | Apr 28, 2025 | Substantially Equivalent | Philips Ultrasound LLC |
| K242321 | Kosmos | Apr 25, 2025 | Substantially Equivalent | EchoNous, Inc. |
| K250228 | eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) | Apr 23, 2025 | Substantially Equivalent | eSonic Technology (Wuhan) Co., LTD |
| K250177 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Apr 10, 2025 | Substantially Equivalent | Philips Ultrasound LLC |
| K243298 | Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System | Apr 03, 2025 | Substantially Equivalent | Carbon (Shenzhen) Medical Device Co., Ltd. |
| K243178 | Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di | Mar 31, 2025 | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. |
| K250214 | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) | Feb 20, 2025 | Substantially Equivalent | Edan Instruments Inc. |
| K242681 | NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25) | Feb 20, 2025 | Substantially Equivalent | Nurodata Inc. |
| K243702 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System | Feb 12, 2025 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K243628 | Vivid T9/Vivid T8 | Feb 11, 2025 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K243620 | Vivid iq | Feb 11, 2025 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K243794 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Feb 06, 2025 | Substantially Equivalent | Philips Ultrasound LLC |
| K243502 | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) | Jan 17, 2025 | Substantially Equivalent | Olympus Medical Systems Corporation |
| K241949 | Digital Color Doppler Ultrasound System (P60 Series) | Jan 17, 2025 | Substantially Equivalent | Sonoscape Medical Corp. |
| K242168 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | Dec 20, 2024 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary care Diagnostics |
| K240676 | ULTIMUS Series Ultrasound Diagnostic System | Dec 16, 2024 | Substantially Equivalent | Vinno Technology (Suzhou) Co.,Ltd |
| K242020 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Dec 12, 2024 | Substantially Equivalent | Philips Ultrasound LLC |
| K243132 | Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Doppler Ultrasound Imaging System (Readius P8); Digital Color Doppler Ultrasound Imaging System (Readius V6); Digital Color Doppler Ultrasound Imaging System (Readius C6) | Dec 10, 2024 | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. |
| K242511 | V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System | Dec 10, 2024 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K242444 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Nov 27, 2024 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K242523 | ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound System | Nov 19, 2024 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K243299 | ACUSON Redwood Diagnostic Ultrasound System | Nov 15, 2024 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K242800 | The 5000 Compact Series Ultrasound Systems | Nov 15, 2024 | Substantially Equivalent | Philips Ultrasound LLC |
| K242231 | Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System | Nov 08, 2024 | Substantially Equivalent | Shenzhen Mindray Bio-medical Electronics Co., LTD. |
| K241554 | Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) | Oct 24, 2024 | Substantially Equivalent | Telefield Medical Imaging (Shenzhen) Limited |
| K241971 | HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System | Oct 11, 2024 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K240980 | EPIQ Series Diagnostic Ultrasound System | Oct 07, 2024 | Substantially Equivalent | Philips Ultrasound LLC |
| K242005 | Versana Premier; Versana Premier Lotus; LOGIQ F | Oct 02, 2024 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K242223 | SuperSonic HepaVu | Sep 20, 2024 | Substantially Equivalent | Supersonic Imagine |
| K234153 | EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) | Sep 18, 2024 | Substantially Equivalent | EdgeLife Technologies LLC |
| K241201 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System | Sep 16, 2024 | Substantially Equivalent | Shenzhen Mindray Bio-medical Electronics Co., Ltd. |
| K241582 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) | Sep 12, 2024 | Substantially Equivalent | Canon Medical Systems Corporation |
| K241432 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System | Sep 12, 2024 | Substantially Equivalent | Shenzhen Mindray Bio-medical Electronics Co., LTD. |
| K241380 | FETOLY-HEART | Sep 11, 2024 | Substantially Equivalent | Diagnoly |
| K241161 | Ultrasound Imaging System (LK128L); Ultrasound Imaging System (LK128LH); Ultrasound Imaging System (LK128C); Ultrasound Imaging System (LK128M); Ultrasound Imaging System (LK128PA); Ultrasound Imaging System (LK128E); Ultrasound Imaging System (LU700C); Ultrasound Imaging System (LU700L); Ultrasound Imaging System (LU710L); Ultrasound Imaging System (LU710LH); Ultrasound Imaging System (LU710C); Ultrasound Imaging System (LU710M); Ultrasound Imaging System (LU710PA); Ultrasound Imaging | Sep 11, 2024 | Substantially Equivalent | Leltek Inc. |
| K241051 | Vave Wireless Ultrasound System | Aug 30, 2024 | Substantially Equivalent | Vave Health, Inc |
| K233826 | Kosmos | Aug 29, 2024 | Substantially Equivalent | EchoNous, Inc. |
| K241979 | Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) | Aug 22, 2024 | Substantially Equivalent | Beijing Konted Medical Technology Co.,Ltd |
| K233697 | SonoMax Series Digital Color Doppler Ultrasound System | Aug 09, 2024 | Substantially Equivalent | CHISON Medical Technologies Co., Ltd. |
| K240906 | TE Air Diagnostic Ultrasound System | Jul 23, 2024 | Substantially Equivalent | Shenzhen Mindray Bio-medical Electronics Co., LTD. |
| K240704 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System | Jul 22, 2024 | Substantially Equivalent | Siemens Medical Solutions, USA, Inc. |
| K240631 | V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System | Jun 21, 2024 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K240684 | Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System | Jun 17, 2024 | Substantially Equivalent | Shenzhen Mindray Bio-medical Electronics Co., LTD. |
| K233955 | Clarius OB AI | Jun 14, 2024 | Substantially Equivalent | Clarius Mobile Health Corp. |
| K240516 | RS85 Diagnostic Ultrasound System | Jun 12, 2024 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K233610 | ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System | Jun 12, 2024 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K240206 | Venue Sprint | Jun 10, 2024 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K240111 | Venue | Jun 10, 2024 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K240053 | Venue Go | Jun 10, 2024 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K234106 | Venue Fit | Jun 10, 2024 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K233841 | HD80 Series Ultrasound Diagnostic System | May 16, 2024 | Substantially Equivalent | Qingdao Hisense Medical Equipment Co., Ltd |
| K232908 | Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) | May 02, 2024 | Substantially Equivalent | Contec Medical Systems Co., Ltd. |
| K240406 | Sonio Detect | Apr 26, 2024 | Substantially Equivalent | Sonio |
| K240850 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems | Apr 24, 2024 | Substantially Equivalent | Philips Ultrasound LLC |
| K240115 | Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System | Apr 22, 2024 | Substantially Equivalent | Shenzhen Mindray Bio-medical Electronics Co., LTD. |
| K231930 | Digital Ultrasonic Diagnostic Imaging System (Model: F6) | Mar 22, 2024 | Substantially Equivalent | GuangDong Youkey Medical Co., Ltd. |
| K233692 | Voluson Signature 20, Voluson Signature 18 | Mar 07, 2024 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary care Diagnostics, |
| K233439 | HD60 Series Ultrasound Diagnostic System | Feb 21, 2024 | Substantially Equivalent | Qingdao Hisense Medical Equipment Co., Ltd |
| K231659 | MS55 Plus Digital Color Doppler Ultrasound System (MS55); P25 Expert Digital Color Doppler Ultrasound System (P25 Expert); P12 Plus Digital Color Doppler Ultrasound System (P12 Plus); P11 Plus Portable Digital Color Doppler Ultrasound System (P11 Plus); P9 Plus Ultrasound Diagnostic System (P9 Plus); P3 Plus Ultrasound Diagnostic System (P3 Plus) | Feb 15, 2024 | Substantially Equivalent | Medisono |
| K233788 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Feb 13, 2024 | Substantially Equivalent | Philips Ultrasound LLC |
| K233394 | Gem Flow Now (GEM2770-FN) | Jan 28, 2024 | Substantially Equivalent | Synovis Micro Companies Alliance |
| K233195 | Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System | Jan 24, 2024 | Substantially Equivalent | Canon Medical Systems Corporation |
| K232285 | U-Lite PRO | Jan 11, 2024 | Substantially Equivalent | Sonoscanner SARL |
| K232808 | Butterfly iQ3 Ultrasound System | Jan 04, 2024 | Substantially Equivalent | Butterfly Network, Inc. |
| K233734 | Interson USB Ultrasound System | Dec 22, 2023 | Substantially Equivalent | Interson Corporation |
| K233112 | HM70 EVO Diagnostic Ultrasound System | Dec 21, 2023 | Substantially Equivalent | Samsung Medison CO., LTD. |
| K231354 | Pocket Ultrasound System (C10) | Dec 20, 2023 | Substantially Equivalent | Beijing Konted Medical Technology Co., Ltd. |
| K232381 | LOGIQ Totus | Dec 07, 2023 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary care Diagnostics, |
| K233597 | Sonosite LX Ultrasound System | Dec 06, 2023 | Substantially Equivalent | FUJIFILM SonoSite Inc. |
| K233545 | EPIQ Series Diagnostic Ultrasound System | Nov 30, 2023 | Substantially Equivalent | Philips Ultrasound LLC |
| K230179 | 6440 MyLabX90 | Nov 29, 2023 | Substantially Equivalent | Esaote S.p.A. |
| K232988 | Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System | Nov 21, 2023 | Substantially Equivalent | Canon Medical Systems Corporation |
| K231941 | ARIETTA x10 | Nov 20, 2023 | Substantially Equivalent | Fujifilm Healthcare Americas Corporation |
| K231989 | LOGIQ E10s, LOGIQ Fortis | Nov 07, 2023 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostic, |
| K231966 | LOGIQ E10 | Nov 07, 2023 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary care Diagnostics, |
| K232186 | LOGIQ e | Nov 03, 2023 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostic, |
| K232145 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System | Oct 30, 2023 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K231965 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | Oct 30, 2023 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K232500 | Lumify Diagnostic Ultrasound System | Oct 26, 2023 | Substantially Equivalent | Philips Ultrasound |
| K231685 | TE Air Diagnostic Ultrasound System | Oct 26, 2023 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| K231509 | Aco Apache Ultrasound System | Oct 24, 2023 | Substantially Equivalent | Aco Healthcare Co., Ltd. |
| K231764 | Ultrasound System 1300 | Oct 23, 2023 | Substantially Equivalent | BK Medical Aps |
| K232704 | Clarius Ultrasound Scanner | Oct 05, 2023 | Substantially Equivalent | Clarius Mobile Health Corp. |
| K231772 | V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System | Oct 03, 2023 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K232617 | ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System | Sep 26, 2023 | Substantially Equivalent | Siemens Medical Solutions, USA, Inc |
| K232336 | ES Series V2 | Sep 26, 2023 | Substantially Equivalent | E-Scopics |
| K230066 | Carnation series Diagnostic Ultrasound System | Sep 15, 2023 | Substantially Equivalent | Shenzhen Wisonic Medical Technology Co., Ltd. |
| K231301 | Vscan Air | Aug 15, 2023 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K230365 | Sonio Detect | Jul 25, 2023 | Substantially Equivalent | Sonio |
| K230160 | VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E | Jun 23, 2023 | Substantially Equivalent | Vinno Technology (Suzhou) Co., Ltd. |
| K230346 | Voluson SWIFT; Voluson SWIFT+ | Jun 20, 2023 | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC |
| K223920 | VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P | Jun 17, 2023 | Substantially Equivalent | VINNO Technology (Suzhou) Co.,Ltd |
| K223917 | VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P | Jun 17, 2023 | Substantially Equivalent | VINNO Technology (Suzhou) Co.,Ltd |
| K230768 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System | Jun 09, 2023 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
| K231190 | EPIQ Series Diagnostic Ultrasound System | May 12, 2023 | Substantially Equivalent | Philips Ultrasound LLC |
| K223771 | Lumify Diagnostic Ultrasound System | May 04, 2023 | Substantially Equivalent | Philips Ultrasound |
| K230084 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound System | Apr 21, 2023 | Substantially Equivalent | Samsung Medison CO., LTD. |
| K223564 | X-CUBE 50, X-CUBE 60 | Apr 17, 2023 | Substantially Equivalent | Alpinion Medical Systems Co., Ltd. |
| K223830 | Ultrasound System 2300 | Apr 11, 2023 | Substantially Equivalent | BK Medical Aps |
| K223570 | SonoAir Series Digital Color Doppler Ultrasound System | Mar 31, 2023 | Substantially Equivalent | CHISON Medical Technologies Co., Ltd. |
| K223017 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 | Mar 31, 2023 | Substantially Equivalent | Canon Medical Systems Corporation |
| K223832 | Vivid S60N, Vivid S70N | Feb 16, 2023 | Substantially Equivalent | GE Medical System Ultrasound and Primary Care Diagnostics |
| K223407 | Versana Essential | Feb 15, 2023 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K230207 | ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System | Feb 13, 2023 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K223387 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Feb 13, 2023 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K222596 | S90 Exp Series Digital Color Doppler Ultrasound System | Feb 10, 2023 | Substantially Equivalent | Sonoscape Medical Corp. |
| K222928 | Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System | Feb 07, 2023 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
| K223735 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System | Feb 06, 2023 | Substantially Equivalent | Siemens Medical Solutions USA, Inc |
| K221911 | VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP | Dec 21, 2022 | Substantially Equivalent | VINNO Technology (Suzhou) Co.,Ltd. |
| K222441 | Ultrasound System 2300 | Dec 07, 2022 | Substantially Equivalent | BK Medical Aps |
| K220983 | ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System | Nov 11, 2022 | Substantially Equivalent | ImSonic Medical China, INC. |
| K222754 | ViewMate Multi Ultrasound System | Nov 09, 2022 | Substantially Equivalent | Shenzhen Mindray Bio-Meidcal Electronics Co., LTD |
| K222198 | Exo Iris (El2001) | Nov 09, 2022 | Substantially Equivalent | Exo Imaging Inc. |
| K222191 | Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 | Oct 28, 2022 | Substantially Equivalent | SuperSonic Imagine |
| K222365 | Leltek Ultrasound Imaging System (Model: LU700 Series) | Oct 25, 2022 | Substantially Equivalent | Leltek Inc |
| K221093 | X-CUBE 70, X-CUBE 90 | Oct 14, 2022 | Substantially Equivalent | Alpinion Medical Systems Co., Ltd. |
| K220857 | X-CUBE 50, X-CUBE 60 | Oct 13, 2022 | Substantially Equivalent | Alpinion Medical Systems Co., Ltd. |
| K211321 | Wireless Probe Type Ultrasound Scanner (Model: CProbe; Type: Type C, Type L, Type CT, Type CL) | Oct 13, 2022 | Substantially Equivalent | Guangzhou Sonostar Technologies Co., Ltd. |
| K220169 | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) | Oct 11, 2022 | Substantially Equivalent | Bionet Co., Ltd. |
| K221496 | Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System | Sep 29, 2022 | Substantially Equivalent | Shenzhen Mindray Bio-medical Electronics Co., Ltd |
| K221300 | Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System | Sep 29, 2022 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
| K222648 | 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) | Sep 27, 2022 | Substantially Equivalent | Philips Ultrasound LLC |
| K221089 | P12 Elite Series Digital Color Doppler Ultrasound System | Sep 15, 2022 | Substantially Equivalent | Sonoscape Medical Corp. |
| K221140 | P20 Elite Series Digital Color Doppler Ultrasound System | Sep 13, 2022 | Substantially Equivalent | Sonoscape Medical Corp. |
| K221568 | KOLO Evolution XHD Series Ultrasound Diagnostic System | Sep 12, 2022 | Substantially Equivalent | Kolo Medical (Suzhou) Co., Ltd |
| K221599 | HS40 Diagnostic Ultrasound System | Aug 22, 2022 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K221190 | ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System | Aug 16, 2022 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K220882 | Vivid E80, Vivid E90, Vivid E95 | Jul 22, 2022 | Substantially Equivalent | GE Medical Systems Ultrasound and |
| K221148 | Vivid iq | Jul 18, 2022 | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC |
| K221147 | Vivid T8, Vivid T9 | Jul 18, 2022 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K220619 | Vivid S60N, Vivid S70N | Jul 15, 2022 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K213009 | Transcranial Doppler Ultrasound System | Jul 08, 2022 | Substantially Equivalent | Shenzhen Delica Medical Equipment Co., Ltd. |
| K220975 | V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System | Jun 29, 2022 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K220851 | Venue | Jun 27, 2022 | Substantially Equivalent | GE Medical Systems |
| K220848 | Venue Fit | Jun 27, 2022 | Substantially Equivalent | GE Medical Systems |
| K220993 | Ultrasound System SONIMAGE MX1 | Jun 23, 2022 | Substantially Equivalent | Konica Minolta, INC. |
| K220800 | Venue Go | Jun 21, 2022 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K221117 | RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System | Jun 17, 2022 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K221500 | ACUSON Sequoia Diagnostic Ultrasound System | Jun 14, 2022 | Substantially Equivalent | Siemens Medical Solutions USA, Inc |
| K213862 | HD60 Series Ultrasound Diagnostic System | Jun 08, 2022 | Substantially Equivalent | Qingdao Hisense Medical Equipment Co., Ltd |
| K220358 | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 | Jun 06, 2022 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K211665 | SONON Ultrasound Imaging System, Model: SONON300C | May 16, 2022 | Substantially Equivalent | HEALCERION CO., LTD. |
| K220446 | Versana Balance | May 11, 2022 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K220269 | HM70 EVO Diagnostic Ultrasound System | May 06, 2022 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K220295 | ARIETTA 50 | Apr 29, 2022 | Substantially Equivalent | FUJIFILM Healthcare Corporation |
| K212400 | SONON Ultrasound Imaging System, Model: SONON 500L | Apr 22, 2022 | Substantially Equivalent | Healcerion Co., Ltd |
| K220490 | ImaCor Zura Handheld ZHH-010 | Apr 08, 2022 | Substantially Equivalent | ImaCor Inc |
| K220043 | HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System | Apr 05, 2022 | Substantially Equivalent | Samsung Medison Co., LTD |
| K220242 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System | Mar 25, 2022 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
| K214039 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | Mar 22, 2022 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K212960 | Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 | Mar 22, 2022 | Substantially Equivalent | Canon Medical Systems Corporation |
| K220051 | TE Air Diagnostic Ultrasound System | Mar 04, 2022 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., LTD |
| K213279 | NovaGuide 2 Intelligent Ultrasound | Mar 02, 2022 | Substantially Equivalent | NovaSignal Corporation |
| K211746 | Pocket Ultrasound System | Feb 18, 2022 | Substantially Equivalent | GuangDong Youkey Medical Co., Ltd. |
| K213689 | Voluson P6, Voluson P8 | Feb 17, 2022 | Substantially Equivalent | GE Healthcare |
| K213487 | ACUSON P500 Ultrasound System | Feb 11, 2022 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K211248 | ArtUs | Feb 11, 2022 | Substantially Equivalent | Telemed |
| K213523 | X-CUBE i8, X-CUBE i9 | Jan 28, 2022 | Substantially Equivalent | Alpinion Medical Systems Co., Ltd. |
| K212333 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 | Jan 24, 2022 | Substantially Equivalent | Canon Medical Systems Corporation |
| K213642 | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert | Jan 13, 2022 | Substantially Equivalent | GE Healthcare |
| K213102 | ES1 System | Jan 11, 2022 | Substantially Equivalent | E-Scopics |
| K213763 | Sonosite PX Ultrasound System | Dec 27, 2021 | Substantially Equivalent | FUJIFILM Sonosite, Inc. |
| K211886 | Clivia series Diagnostic Ultrasound System | Dec 02, 2021 | Substantially Equivalent | Shenzhen Wisonic Medical Technology Co.Ltd. |
| K212265 | TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System | Nov 16, 2021 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co.,LTD |
| K213436 | Clarius Ultrasound Scanner | Nov 15, 2021 | Substantially Equivalent | Clarius Mobile Health Corp. |
| K212900 | MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System | Nov 05, 2021 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., LTD. |
| K210432 | LELTEK Ultrasound Imaging System (Model: LU700 Series) | Nov 03, 2021 | Substantially Equivalent | Leltek Inc |
| K212704 | Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System | Sep 24, 2021 | Substantially Equivalent | Philips Medical Systems |
| K212021 | 6430 MyLabX75, 6430 MyLab XPro75 | Sep 16, 2021 | Substantially Equivalent | Esaote S.p.A. |
| K211488 | LOGIQ E10 | Sep 10, 2021 | Substantially Equivalent | GE Healthcare |
| K210438 | Versana Premier | Sep 10, 2021 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K211824 | HERA W9, HERA W10 Diagnostic Ultrasound System | Sep 09, 2021 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K211945 | V8 Diagnostic Ultrasound System | Sep 08, 2021 | Substantially Equivalent | Samsung Medison CO., LTD. |
| K211597 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System | Sep 08, 2021 | Substantially Equivalent | Philips Medical Systems |
| K211524 | LOGIQ E10s, LOGIQ Fortis | Aug 27, 2021 | Substantially Equivalent | GE Healthcare |
| K211527 | Exo Iris | Aug 20, 2021 | Substantially Equivalent | Exo Imaging Inc. |
| K210317 | Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System | Aug 19, 2021 | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) |
| K210318 | Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System | Aug 18, 2021 | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) |
| K211300 | X-CUBE 90 | Aug 09, 2021 | Substantially Equivalent | Alpinion Medical Systems Co., Ltd. |
| K211299 | X-CUBE 70 | Aug 09, 2021 | Substantially Equivalent | Alpinion Medical Systems Co., Ltd. |
| K212100 | Kosmos | Aug 06, 2021 | Substantially Equivalent | EchoNous, Inc. |
| K210154 | Labat series Diagnostic Ultrasound System | Jul 30, 2021 | Substantially Equivalent | Shenzhen Wisonic Medical Technology Co.,Ltd. |
| K211859 | ACUSON Sequoia Diagnostic Ultrasound System | Jul 20, 2021 | Substantially Equivalent | Siemens Medical Solutions USA, Inc |
| K210713 | HM70 EVO Diagnostic Ultrasound System | Jul 09, 2021 | Substantially Equivalent | Samsung Medison CO., LTD. |
| K211337 | DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System | Jul 01, 2021 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., LTD |
| K203645 | Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 | Jun 29, 2021 | Substantially Equivalent | SuperSonic Imagine |
| K211232 | Apache Ultrasound System | Jun 25, 2021 | Substantially Equivalent | Aco Healthcare Co,. Ltd. |
| K203657 | Vu-Path Ultrasound System | Jun 25, 2021 | Substantially Equivalent | Crystalline Medical |
| K210959 | RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System | Jun 24, 2021 | Substantially Equivalent | Samsung Medison CO., LTD. |
| K210699 | Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System | Jun 10, 2021 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., LTD |
| K210416 | M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System | Jun 10, 2021 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., LTD |
| K211216 | Vivid S60N / Vivid S70N | Jun 09, 2021 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K210426 | HS40 Diagnostic Ultrasound System | May 13, 2021 | Substantially Equivalent | Samsung Medison CO., LTD. |
| K210068 | HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System | Apr 09, 2021 | Substantially Equivalent | Samsung Medison CO., LTD. |
| K202785 | Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System | Apr 08, 2021 | Substantially Equivalent | Shenzhen Mindray Bio-Meidcal Electronics Co., LTD |
| K210743 | ACUSON Redwood Diagnostic Ultrasound System | Apr 01, 2021 | Substantially Equivalent | Siemens Medical Solutions USA, Inc |
| K203391 | TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System | Mar 23, 2021 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., LTD |
| K202658 | Vivid E80/ Vivid E90/ Vivid E95 | Mar 05, 2021 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K201965 | SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System | Mar 02, 2021 | Substantially Equivalent | Chison Medical Technologies Co., Ltd. |
| K201968 | SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System | Feb 26, 2021 | Substantially Equivalent | Chison Medical Technologies Co., Ltd. |
| K201967 | SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System | Feb 26, 2021 | Substantially Equivalent | Chison Medical Technologies Co., Ltd. |
| K201971 | SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System | Feb 25, 2021 | Substantially Equivalent | Chison Medical Technologies Co., Ltd. |
| K201969 | SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System | Feb 25, 2021 | Substantially Equivalent | Chison Medical Technologies Co., Ltd. |
| K203406 | Lumify Diagnostic Ultrasound System | Feb 23, 2021 | Substantially Equivalent | Philips Ultrasound, Inc. |
| K202856 | Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28 | Jan 25, 2021 | Substantially Equivalent | Edan Instruments, Inc. |
| K202742 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory | Jan 25, 2021 | Substantially Equivalent | Viasonix Ltd. |
| K203114 | LOGIQ P10, LOGIQ P9, LOGIQ P8 | Jan 08, 2021 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K203137 | Venue Fit | Dec 29, 2020 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K202455 | Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems | Dec 29, 2020 | Substantially Equivalent | Supersonic Imagine |
| K202233 | Venue Go | Nov 18, 2020 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K202132 | Venue | Nov 13, 2020 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K202074 | Apache Ultrasound System (Model C62) | Nov 12, 2020 | Substantially Equivalent | Compal Electronics, Inc. |
| K203128 | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS | Nov 09, 2020 | Substantially Equivalent | Olympus Medical Systems Corp. |
| K201990 | DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System | Nov 09, 2020 | Substantially Equivalent | Shenzhen Mindray Bio-medical Electronics Co., Ltd |
| K202422 | Arietta 65 | Nov 04, 2020 | Substantially Equivalent | Hitachi Healthcare Americas |
| K202556 | HS30 Diagnostic Ultrasound System | Oct 30, 2020 | Substantially Equivalent | Samsung Medison Co., LTD |
| K201988 | T-Lite | Oct 30, 2020 | Substantially Equivalent | Sonoscanner |
| K201768 | Voluson E10 | Oct 22, 2020 | Substantially Equivalent | GE Healthcare |
| K202737 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System | Oct 16, 2020 | Substantially Equivalent | Canon Medical Systems Corporation |
| K202683 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System | Oct 15, 2020 | Substantially Equivalent | Siemens Medical Solutions, USA, Inc. |
| K202364 | Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 | Oct 15, 2020 | Substantially Equivalent | Canon Medical Systems Corporation |
| K201828 | Voluson SWIFT, Voluson SWIFT+ | Oct 11, 2020 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K201972 | Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 | Oct 08, 2020 | Substantially Equivalent | Canon Medical Systems Corporation |
| K202406 | Butterfly iQ Ultrasound System | Sep 16, 2020 | Substantially Equivalent | Butterfly Network, Inc. |
| K200851 | Vivid T8, Vivid T9 | Sep 09, 2020 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K200708 | Vivid iq | Sep 09, 2020 | Substantially Equivalent | GE Medical Systems Ultrasound and |
| K202216 | EPIQ Series Diagnostic Ultrasound Systems | Sep 02, 2020 | Substantially Equivalent | Philips Ultrasound, Inc. |
| K202160 | Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System | Sep 01, 2020 | Substantially Equivalent | FUJIFILM SonoSite Inc. |
| K201693 | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | Aug 21, 2020 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| K200780 | XBit Series Digital Color Doppler Ultrasound System | Aug 05, 2020 | Substantially Equivalent | CHISON Medical Technologies Co., Ltd. |
| K201059 | S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System | Jul 30, 2020 | Substantially Equivalent | Sonoscape Medical Corp. |
| K200643 | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous | Jul 24, 2020 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., LTD |
| K200743 | Vivid E80/ Vivid E90/ Vivid E95 | Jul 23, 2020 | Substantially Equivalent | GE Medical Systems Ultrasound and |
| K200497 | Vivid S60N, Vivid S70N | Jul 16, 2020 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K200450 | X-Cube 70 | Jul 10, 2020 | Substantially Equivalent | Alpinion Medical Systems Co., Ltd. |
| K200449 | X-Cube 90 | Jul 10, 2020 | Substantially Equivalent | Alpinion Medical Systems Co., Ltd. |
| K201633 | Terason uSmart 3200T Plus Ultrasound System | Jul 02, 2020 | Substantially Equivalent | Teratech Corporation |
| K200138 | Versana Premier | Jul 01, 2020 | Substantially Equivalent | GE Medical Systems Ultrasound and |
| K201462 | ACUSON Sequoia Diagnostic Ultrasound System | Jun 24, 2020 | Substantially Equivalent | Siemens Medical Solutions USA, Inc |
| K200998 | Versana Active | Jun 11, 2020 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K200979 | DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System | May 28, 2020 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., LTD. |
| K201130 | ACUSON Juniper Diagnostic Ultrasound System | May 26, 2020 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K192879 | Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System | May 21, 2020 | Substantially Equivalent | Edan Instruments, Inc |
| K200964 | Sonosite PX Ultrasound System | May 08, 2020 | Substantially Equivalent | FUJIFILM SonoSite, Inc. |
| K200699 | HS70A Diagnostic Ultrasound System | May 07, 2020 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K201012 | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System | May 01, 2020 | Substantially Equivalent | Philips Ultrasound, Inc. |
| K200585 | Acuson SC2000 Diagnostic Ultrasound System | Apr 22, 2020 | Substantially Equivalent | Siemens Medical Solutions, USA, Inc. |
| K200158 | LOGIQ E10 | Apr 17, 2020 | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC |
| K200707 | ACUSON Sequoia Diagnostic Ultrasound System | Apr 15, 2020 | Substantially Equivalent | Siemens Medical Solutions USA, Inc |
| K200644 | ACUSON Freestyle Diagnostic Ultrasound System | Apr 10, 2020 | Substantially Equivalent | Siemens Medical Solutions USA, Inc |
| K200001 | MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System | Apr 09, 2020 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., LTD |
| K200411 | Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System | Apr 08, 2020 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., LTD. |
| K200339 | HS40 Diagnostic Ultrasound System | Apr 07, 2020 | Substantially Equivalent | Samsung Medison Co., LTD |
| K200251 | Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System | Apr 02, 2020 | Substantially Equivalent | ShenZhen Mindray Bio-Medical Electronics Co., Ltd |
| K200119 | LOGIQ E10s | Apr 01, 2020 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K193518 | KOSMOS | Mar 26, 2020 | Substantially Equivalent | EchoNous, Inc. |
| K192388 | SonoVision Ultrasound Imaging System | Mar 12, 2020 | Substantially Equivalent | Tissue Differentiation Intelligence, LLC |
| K200304 | EPIQ Diagnostic Ultrasound System | Mar 06, 2020 | Substantially Equivalent | Philips Ultrasound, Inc. |
| K191235 | Leltek Ultrasound Imaging System | Feb 12, 2020 | Substantially Equivalent | Leltek Inc |
| K191347 | Paragon XHD Diagnostic Ultrasound System | Feb 07, 2020 | Substantially Equivalent | Shenzhen Wisonic Medical Technology Co., Ltd. |
| K193257 | ACUSON Sequoia Diagnostic Ultrasound System | Jan 31, 2020 | Substantially Equivalent | Siemens Medical Solutions USA, Inc |
| K193510 | Terason uSmart3200T Ultrasound System | Jan 28, 2020 | Substantially Equivalent | Teratech Corporation |
| K190120 | VINNO 8, VINNO 6, VINNO 5 | Jan 23, 2020 | Substantially Equivalent | VINNO Technology (Suzhou) Co., Ltd. |
| K192903 | RS85 Diagnostic Ultrasound System | Jan 06, 2020 | Substantially Equivalent | Samsung Medison Co., Ltd |
| K192410 | ZS3 and z.one pro Ultrasound Systems | Dec 19, 2019 | Substantially Equivalent | ShenZhen Mindray Bio-Medical Electronics Co., Ltd |
| K192152 | DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System | Dec 13, 2019 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., LTD |
| K192505 | HS50/HS60 Diagnostics Ultrasound System | Dec 12, 2019 | Substantially Equivalent | Samsung Medison CO., LTD. |
| K192319 | HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System | Dec 10, 2019 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K192157 | 6450 Ultrasound system | Nov 22, 2019 | Substantially Equivalent | Esaote, S.p.A. |
| K191007 | Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems | Oct 25, 2019 | Substantially Equivalent | Supersonic Imagine |
| K192835 | ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System | Oct 22, 2019 | Substantially Equivalent | Siemens Medical Solutions, USA, Inc. |
| K192303 | ExactVu High Resolution Micro-Ultrasound System | Oct 01, 2019 | Substantially Equivalent | Exact Imaging Inc. |
| K192030 | RS80 EVO Diagnostic Ultrasound System | Sep 19, 2019 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K192254 | InnoSight Diagnostic Ultrasound System | Sep 18, 2019 | Substantially Equivalent | Qisda Corporation |
| K191663 | Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 | Sep 18, 2019 | Substantially Equivalent | Canon Medical Systems Corporation |
| K192226 | Lumify Diagnostic Ultrasound System | Sep 06, 2019 | Substantially Equivalent | Philips Healthcare |
| K192159 | Voluson E6, Voluson E8, Voluson E10 | Aug 29, 2019 | Substantially Equivalent | GE Healthcare |
| K192107 | Clarius Ultrasound Scanner | Aug 29, 2019 | Substantially Equivalent | Clarius Mobile Health Corp. |
| K191922 | ACUSON P200 Diagnostic Ultrasound System | Aug 15, 2019 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K191798 | Versana Active | Aug 09, 2019 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K191792 | Versana Balance | Aug 09, 2019 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K191233 | ARIETTA 750 | Aug 09, 2019 | Substantially Equivalent | Hitachi Healthcare Americas |
| K191467 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 | Jul 19, 2019 | Substantially Equivalent | Canon Medical Systems Corporation |
| K183041 | Full Digital Colour Doppler Ultrasonic Diagnostic System | Jul 10, 2019 | Substantially Equivalent | Wuhan Zoncare Bio-medical Electronics Co., Ltd |
| K190228 | Transcranial Doppler Ultrasound System | Jun 13, 2019 | Substantially Equivalent | Shenzhen Delica Medical Equipment Co., Ltd. |
| K191115 | RS85 Diagnostic Ultrasound System | Jun 12, 2019 | Substantially Equivalent | Samsung Medison Co., Ltd |
| K191055 | HS40 Diagnostic Ultrasound System | Jun 12, 2019 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K191072 | 7410 Ultrasound System (MyLabSigma) | Jun 10, 2019 | Substantially Equivalent | Esaote S.p.A. |
| K190444 | HERA I10 Diagnostic Ultrasound System | May 22, 2019 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K191023 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX | May 16, 2019 | Substantially Equivalent | Viasonix Ltd. |
| K190995 | ExactVu High Resolution Micro-Ultrasound System | May 10, 2019 | Substantially Equivalent | Exact Imaging, Inc. |
| K190989 | 6400 Ultrasound System (MyLabX6, MyLabX7) | May 10, 2019 | Substantially Equivalent | Esaote, S.p.A. |
| K183660 | DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System | Apr 09, 2019 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., LTD |
| K182175 | TCD-X | Apr 05, 2019 | Substantially Equivalent | Atys |
| K183377 | DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System | Apr 04, 2019 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., LTD |
| K190248 | ARIETTA 50 | Apr 02, 2019 | Substantially Equivalent | Hitachi Healthcare Americas |
| K190447 | 7400 Ultrasound Systems | Apr 01, 2019 | Substantially Equivalent | Navigant Consulting - on behalf of Esaote S.p.A. |
| K183575 | ACUSON S3000, S2000 Diagnostic Ultrasound System | Mar 20, 2019 | Substantially Equivalent | Siemens Healthineers |
| K190476 | FUJIFILM Sonosite Vevo MD Imaging System | Mar 15, 2019 | Substantially Equivalent | FUJIFILM SonoSite, Inc. |
| K190206 | DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System | Mar 08, 2019 | Substantially Equivalent | Shenzhen Mindray Bio-medical Electronics Co., LTD |
| K182628 | Imagio Ultrasound Imaging System | Mar 05, 2019 | Substantially Equivalent | Seno Medical Instruments, Inc. |
| K182932 | RS85 Diagnostic Ultrasound System | Feb 15, 2019 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K183235 | SonoSite SII Ultrasound System | Feb 07, 2019 | Substantially Equivalent | FUJIFILM SonoSite, Inc. |
| K182648 | X5 Series Digital Color Doppler Ultrasound System | Jan 29, 2019 | Substantially Equivalent | Sonoscape Medical Corp. |
| K183456 | Aloka Arietta 850 | Jan 28, 2019 | Substantially Equivalent | Hitachi Healthcare Americas |
| K183362 | Venue GO | Jan 28, 2019 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K182594 | E-CUBE i7 | Jan 24, 2019 | Substantially Equivalent | Alpinion Medical Systems Co., Ltd. |
| K182894 | HM70A Diagnostic Ultrasound System | Jan 22, 2019 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K182636 | DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System | Jan 10, 2019 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., LTD |
| K181637 | DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System | Jan 09, 2019 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., LTD |
| K182632 | HS30 Diagnostic Ultrasound System | Jan 08, 2019 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K182845 | minisono | Dec 27, 2018 | Substantially Equivalent | Alpinion Medical Systems Co., Ltd. |
| K182165 | Color Doppler Ultrasound System; Model: mEye1 and mEye2 | Dec 20, 2018 | Substantially Equivalent | Shenzhen Well.D Medical Electronics Co., LTD. |
| K182595 | HERA W10 Diagnostic Ultrasound System | Dec 18, 2018 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K181727 | Vivid iq | Dec 06, 2018 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K183191 | 6420 Ultrasound System | Dec 04, 2018 | Substantially Equivalent | Esaote, S.p.A. |
| K181336 | HS50 / HS60 Diagnostic Ultrasound System | Dec 04, 2018 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K182277 | Versana Premier | Nov 21, 2018 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K182715 | Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System | Nov 20, 2018 | Substantially Equivalent | Shenzhen Wisonic Medical Technology Co., Ltd. |
| K181985 | Voluson E6, Voluson E8, Voluson E10 | Nov 15, 2018 | Substantially Equivalent | GE Healthcare |
| K182603 | Z6 Diagnostic Ultrasound System | Nov 14, 2018 | Substantially Equivalent | Shenzhen Mindray Bio-medical Electronics Co., LTD |
| K182857 | EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | Nov 09, 2018 | Substantially Equivalent | Philips Ultrasound, Inc. |
| K181934 | Vivid T8, Vivid T9 | Nov 06, 2018 | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC |
| K182596 | Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System | Nov 02, 2018 | Substantially Equivalent | Canon Medical Systems Corporation |
| K182427 | Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System | Nov 02, 2018 | Substantially Equivalent | Canon Medical Systems Corporation |
| K182679 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 | Oct 31, 2018 | Substantially Equivalent | Canon Medical Systems Corporation |
| K181685 | Vivid E80, Vivid E90, Vivid E95 | Oct 25, 2018 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K182529 | Xperius Ultrasound System | Oct 23, 2018 | Substantially Equivalent | Philips Ultrasound, Inc. |
| K182450 | Vivid S60N, Vivid S70N | Oct 19, 2018 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K181617 | E-CUBE 8 | Oct 11, 2018 | Substantially Equivalent | Alpinion Medical Systems Co., Ltd. |
| K181277 | E-CUBE 12 | Sep 28, 2018 | Substantially Equivalent | Alpinion Medical Systems Co., Ltd. |
| K181783 | LOGIQ P9; LOGIQ P7 | Sep 20, 2018 | Substantially Equivalent | GE Healthcare |
| K181313 | BenQ Diagnostic Ultrasound System | Aug 27, 2018 | Substantially Equivalent | Qisda Corporation |
| K180974 | CBit Series Digital Color Doppler Ultrasound System | Aug 17, 2018 | Substantially Equivalent | CHISON Medical Technologies Co., Ltd. |
| K180737 | Ultrasound Scanner System bk2300 | Aug 01, 2018 | Substantially Equivalent | BK Medical ApS |
| K180912 | TE7/TE5 Diagnostic Ultrasound System | Jul 30, 2018 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
| K181485 | EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System | Jul 27, 2018 | Substantially Equivalent | Philips Ultrasound, Inc. |
| K181376 | ARIETTA 65 | Jul 18, 2018 | Substantially Equivalent | Hitachi Healthcare Americas Corporation |
| K173801 | Transcranial Doppler Ultrasound System | Jul 11, 2018 | Substantially Equivalent | Shenzhen Delica Medical Equipment Co., Ltd. |
| K173486 | NTU-USB Ultrasound USB Box | Jul 11, 2018 | Substantially Equivalent | National Taiwan University |
| K180995 | Vscan Extend | Jun 25, 2018 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K181098 | ACUSON SC2000 Diagnostic Ultrasound System | May 31, 2018 | Substantially Equivalent | Siemens Medical Solutions USA, Inc |
| K180572 | AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 | May 29, 2018 | Substantially Equivalent | Supersonic Imagine |
| K180862 | Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System | May 24, 2018 | Substantially Equivalent | Edan Instruments, Inc |
| K180455 | NeuralBot | May 22, 2018 | Substantially Equivalent | Neural Analytics, Inc. |
| K180799 | Clarius Ultrasound Scanner | May 14, 2018 | Substantially Equivalent | Clarius Mobile Health Corp. |
| K173810 | Ventripoint Medical System Plus (VMS+) | May 14, 2018 | Substantially Equivalent | Ventripoint Diagnostics, Ltd. |
| K180409 | HS40 Diagnostic Ultrasound System | May 11, 2018 | Substantially Equivalent | Samsung Medison Co, Ltd. |
| K180461 | Navi e/Navi s/Navi X Diagnostic Ultrasound System | May 09, 2018 | Substantially Equivalent | Shenzhen Wisonic Medical Technology Co., Ltd. |
| K180599 | Venue | May 02, 2018 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K173962 | Viamo c100 TUS-VC100 Diagnostic Ultrasound System | Apr 20, 2018 | Substantially Equivalent | Toshiba Medical Systems Corporation |
| K180704 | SonoSite iViz Ultrasound System | Apr 13, 2018 | Substantially Equivalent | FUJIFILM SonoSite, Inc. |
| K180408 | U60 Diagnostic Ultrasound System | Apr 13, 2018 | Substantially Equivalent | Edan Instruments, Inc. |
| K180535 | Voluson P6 and Voluson P8 | Mar 29, 2018 | Substantially Equivalent | GE Healthcare |
| K180374 | Voluson S8/ Voluson S10/ Voluson S10 Expert | Mar 13, 2018 | Substantially Equivalent | GE Healthcare |
| K173713 | HS70A Diagnostic Ultrasound System | Mar 08, 2018 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K173739 | ALOKA ARIETTA 850 | Feb 28, 2018 | Substantially Equivalent | Hitachi Healthcare Americas Corporation |
| K173569 | Ultrasound System 1300 | Feb 23, 2018 | Substantially Equivalent | BK Medical ApS |
| K173513 | WS80A Diagnostic Ultrasound System | Feb 20, 2018 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K180067 | ACUSON X800 Diagnostic Ultrasound System | Feb 07, 2018 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K173204 | RS85 Diagnostic Ultrasound System | Feb 05, 2018 | Substantially Equivalent | Samsung Medison Co., Ltd |
| K173981 | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System | Feb 02, 2018 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. Ultrasound Group |
| K180039 | ACUSON Juniper Diagnostic Ultrasound System | Feb 01, 2018 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K173957 | ACUSON NX3 Diagnostic Ultrasound System; ACUSON NX3 ELITE Diagnostic Ultrasound System | Feb 01, 2018 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K173291 | 6440 Ultrasound System | Jan 12, 2018 | Substantially Equivalent | Esaote S.p.A |
| K173090 | Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 | Jan 11, 2018 | Substantially Equivalent | Toshiba Medical Systems Corporation |
| K173021 | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems | Jan 09, 2018 | Substantially Equivalent | Supersonic Imagine |
| K173471 | DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic | Jan 08, 2018 | Substantially Equivalent | Shenzhen Mindray Bio-medical Electronics Co., LTD |
| K172860 | Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System | Jan 02, 2018 | Substantially Equivalent | ShenZhen Mindray Bio-Medical Electronics Co., Ltd |
| K163712 | Clover 50/Clover60/Clover70 Diagnostic Ultrasound System | Jan 02, 2018 | Substantially Equivalent | SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD. |
| K173555 | LOGIQ E10 | Dec 20, 2017 | Substantially Equivalent | GE Healthcare |
| K172732 | E-CUBE 8 | Dec 14, 2017 | Substantially Equivalent | ALPINION MEDICAL SYSTEMS Co., Ltd. |
| K173369 | DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System | Dec 13, 2017 | Substantially Equivalent | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd |
| K172276 | Xario 200 Diagnostic Ultrasound System V6.0 | Dec 12, 2017 | Substantially Equivalent | Toshiba Medical Systems Corporation |
| K173000 | Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System | Dec 07, 2017 | Substantially Equivalent | Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) |
| K172993 | P20 Series Digital Color Doppler Ultrasound System | Dec 05, 2017 | Substantially Equivalent | Sonoscape Medical Corp. |
| K173058 | P10 Series Digital Color Doppler Ultrasound System | Dec 01, 2017 | Substantially Equivalent | Sonoscape Medical Corp. |
| K173003 | U50 Diagnostic Ultrasound System | Nov 15, 2017 | Substantially Equivalent | Edan Instruments, Inc. |
| K170859 | Dolphin/IQ and Dolphin/4D | Nov 14, 2017 | Substantially Equivalent | Viasonix Ltd. |
| K173265 | UltraVision 2 Diagnostic Ultrasound System | Nov 07, 2017 | Substantially Equivalent | WinProbe Corporation |
| K173341 | Vivid E80, Vivid E90, Vivid E95 | Nov 02, 2017 | Substantially Equivalent | GE Medical Systems |
| K171708 | ALOKA ARIETTA 850 | Oct 31, 2017 | Substantially Equivalent | Hitachi Healthcare Americas Corporation |
| K171926 | C5 Diagnostic Ultrasound System | Oct 27, 2017 | Substantially Equivalent | Guangzhou Sonostar Technologies Co., Ltd. |
| K172970 | M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound | Oct 25, 2017 | Substantially Equivalent | ShenZhen Mindray Bio-Medical Electronics Co., Ltd |
| K171579 | M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System | Oct 18, 2017 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
| K170085 | SONON Ultrasound Imaging System, Model: 300L | Oct 12, 2017 | Substantially Equivalent | HEALCERION CO., LTD |
| K172059 | LinkQuest Diagnostic Ultrasound System model SQ860 | Oct 05, 2017 | Substantially Equivalent | LinkQuest Inc. |
| K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | Oct 04, 2017 | Substantially Equivalent | Philips Healthcare |
| K172380 | U2 Diagnostic Ultrasound System | Sep 29, 2017 | Substantially Equivalent | Edan Instruments Inc |
| K172342 | Voluson E6, Voluson E8, Voluson E10 | Sep 29, 2017 | Substantially Equivalent | GE Healthcare |
| K172082 | S60 Series Digital Color Doppler Ultrasound System | Sep 21, 2017 | Substantially Equivalent | Sonoscape Medical Corp. |
| K171891 | ZS3 Ultrasound System, z.one pro Ultrasound System | Sep 21, 2017 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
| K172385 | Clarius Ultrasound System | Sep 14, 2017 | Substantially Equivalent | Clarius Mobile Health Corp. |
| K171233 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System | Sep 12, 2017 | Substantially Equivalent | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd |
| K163510 | Poseidon Ultrasound System | Sep 06, 2017 | Substantially Equivalent | BUTTERFLY NETWORK, INC. |
| K172055 | DUS-7000 Digital Color Doppler Ultrasound System | Aug 31, 2017 | Substantially Equivalent | Advanced Instrumentations, Inc |
| K171048 | RS80A Diagnostic Ultrasound System | Aug 24, 2017 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K171900 | Acclarix AX4 Diagnostic Ultrasound System | Aug 18, 2017 | Substantially Equivalent | Edan Instruments, Inc |
| K172162 | ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems | Aug 16, 2017 | Substantially Equivalent | Siemens Healthcare |
| K172374 | ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System | Aug 15, 2017 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K163121 | SmartUs EXT-1M/3M | Aug 10, 2017 | Substantially Equivalent | TELEMED |
| K171070 | WS80A Diagnostic Ultrasound System | Aug 09, 2017 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K172129 | HS40 Diagnostic Ultrasound System | Aug 08, 2017 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K171164 | U-Lite EXP | Aug 03, 2017 | Substantially Equivalent | Sonoscanner |
| K170999 | P50 Series Digital Color Doppler Ultrasound System | Jul 12, 2017 | Substantially Equivalent | SONOSCAPE MEDICAL CORP. |
| K171105 | AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems | Jul 11, 2017 | Substantially Equivalent | Supersonic Imagine |
| K171000 | P60 Series Digital Color Doppler Ultrasound System | Jul 11, 2017 | Substantially Equivalent | SONOSCAPE MEDICAL CORP. |
| K171034 | M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System | Jul 10, 2017 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| K170870 | Site~Rite Halcyon Diagnostic Ultrasound System | Jul 06, 2017 | Substantially Equivalent | CHISON Medical Imaging Co., Ltd. |
| K170714 | Venue | Jun 21, 2017 | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC |
| K170878 | Vivid S60N, Vivid S70N | Jun 14, 2017 | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC |
| K171437 | SonoSite X-Porte Ultrasound System | Jun 12, 2017 | Substantially Equivalent | FujiFilm SonoSite, Inc. |
| K170823 | Vivid E80, Vivid E90, Vivid E95 | Jun 12, 2017 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| K170374 | SonoBook Series Diagnostic Ultrasound System | Jun 06, 2017 | Substantially Equivalent | CHISON Medical Imaging Co., Ltd. |
| K170521 | TRINITY/3D PROSTATE SUITE | May 30, 2017 | Substantially Equivalent | KOELIS |
| K163702 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 | May 30, 2017 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K163505 | ARIETTA PRECISION | May 30, 2017 | Substantially Equivalent | HITACHI, LTD |
| K170303 | E5 Series Digital Color Doppler Ultrasound System | May 19, 2017 | Substantially Equivalent | SONOSCAPE MEDICAL CORP. |
| K170078 | Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT Portable, P12 Trolley, P12 Expert, P25 Trolley, and P25 Expert Trolley | May 17, 2017 | Substantially Equivalent | MEDISONO, LLC |
| K163690 | DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System | Apr 20, 2017 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| K163443 | Interson USB Ultrasound System | Apr 13, 2017 | Substantially Equivalent | Interson Corporation |
| K170445 | LOGIQ S8 | Apr 11, 2017 | Substantially Equivalent | GE Healthcare |
| K170315 | Acuson SC2000 Diagnostic Ultrasound System | Apr 04, 2017 | Substantially Equivalent | Siemens Medical Solutions Inc. |
| K170493 | HS50 / HS60 Diagnostic Ultrasound System | Mar 28, 2017 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K170277 | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System | Mar 23, 2017 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K163082 | 6200 Ultrasound System and 6250 Ultrasound System | Mar 16, 2017 | Substantially Equivalent | ESAOTE S.P.A |
| K163688 | Medisono Ultrasonic Diagnostic Imaging System, models P1, P3, and P10 | Feb 23, 2017 | Substantially Equivalent | MEDISONO, LLC |
| K163691 | HS70A Diagnostic Ultrasound System | Feb 22, 2017 | Substantially Equivalent | Samsung Medison Co., Ltd. |
| K163596 | LOGIQ P9 and LOGIQ P7 | Feb 10, 2017 | Substantially Equivalent | GE HEALTHCARE |
| K162055 | Acclarix LX8 Diagnostic Ultrasound System | Jan 31, 2017 | Substantially Equivalent | EDAN INSTRUMENTS INC |
| K163635 | ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems | Jan 12, 2017 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. Ultrasound Group |
| K163120 | EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound System | Jan 10, 2017 | Substantially Equivalent | Philips Ultrasound, Inc. |
| K163396 | ACUSON P500 Ultrasound System | Jan 04, 2017 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K163427 | X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System | Jan 03, 2017 | Substantially Equivalent | SONOSCAPE MEDICAL CORP. |
| K162902 | ARIETTA Prologue Diagnostic Ultrasound system and Transducers | Dec 15, 2016 | Substantially Equivalent | HITACHI, LTD. |
| K162845 | DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System | Dec 15, 2016 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD |
| K163138 | Clarius Ultrasound System | Nov 30, 2016 | Substantially Equivalent | Clarius Mobile Health Corp. |
| K163077 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | Nov 17, 2016 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K162583 | ALOKA LISENDO 880 | Nov 17, 2016 | Substantially Equivalent | HITACHI, LTD. |
| K163020 | Xperius Ultrasound System | Nov 16, 2016 | Substantially Equivalent | PHILIPS HEALTHCARE |
| K161999 | Aixplorer | Nov 16, 2016 | Substantially Equivalent | SUPERSONIC IMAGINE |
| K162155 | Xario 200 Diagnostic Ultrasound System V5.0 | Nov 01, 2016 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K160442 | Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz Transducers | Oct 21, 2016 | Substantially Equivalent | NEURAL ANALYTICS, INC. |
| K162065 | Ultrasound System SONIMAGE HS1 | Oct 19, 2016 | Substantially Equivalent | KONICA MINOLTA, INC. |
| K160559 | NOBLUS Ultrasound Diagnostic System | Oct 18, 2016 | Substantially Equivalent | HITACHI MEDICAL CORPORATION |
| K161960 | bk2300 | Oct 17, 2016 | Substantially Equivalent | BK MEDICAL APS |
| K162290 | MyLabSix CrystaLine | Oct 14, 2016 | Substantially Equivalent | ESAOTE S.P.A. |
| K162549 | Lumify Ultrasound System | Oct 03, 2016 | Substantially Equivalent | Philips Healthcare |
| K162269 | Voluson E6, Voluson E8, Voluson E10 | Oct 03, 2016 | Substantially Equivalent | GE Healthcare |
| K153539 | RS80A Diagnostic Ultrasound System | Oct 03, 2016 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD. |
| K162187 | Xario 100 Diagnostic Ultrasound System, V5.0 | Sep 30, 2016 | Substantially Equivalent | Toshiba Medical Systems Corporation |
| K162417 | Acuson Freestyle Ultrasound System | Sep 28, 2016 | Substantially Equivalent | Siemens Medical Solutions, Inc. |
| K161843 | Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0 | Sep 21, 2016 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K161439 | E-CUBE 11 | Sep 21, 2016 | Substantially Equivalent | ALPINION MEDICAL SYSTEMS CO., LTD. |
| K162329 | CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System | Sep 14, 2016 | Substantially Equivalent | Philips Healthcare |
| K162172 | EBit Series Diagnostic Ultrasound System | Sep 14, 2016 | Substantially Equivalent | CHISON MEDICAL IMAGING CO., LTD. |
| K162288 | SonoSite iViz Ultrasound System | Sep 08, 2016 | Substantially Equivalent | FUJIFILM SONOSITE, INC. |
| K162267 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System | Sep 06, 2016 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD |
| K162243 | ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System | Sep 06, 2016 | Substantially Equivalent | Siemens Medical Solutions, Inc. |
| K162221 | ACUSON SC2000 Diagnostic Ultrasound System | Sep 06, 2016 | Substantially Equivalent | Siemens Medical Solutions Inc. Ultrasound Group |
| K161168 | MyLabSix Ultrasound System | Sep 02, 2016 | Substantially Equivalent | Esaote Europe B.V. |
| K161588 | Vscan Extend | Aug 31, 2016 | Substantially Equivalent | GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC |
| K162094 | RS80A Diagnostic Ultrasound System | Aug 26, 2016 | Substantially Equivalent | Samsung Medison Co., Ltd |
| K162045 | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System | Aug 18, 2016 | Substantially Equivalent | FUJIFILM SonoSite, Inc. |
| K161706 | Vivid iq | Aug 05, 2016 | Substantially Equivalent | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS L |
| K161224 | LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3 | Aug 05, 2016 | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics LLC |
| K161787 | ACUSON NX2 Diagnostic Ultrasound Systems | Jul 28, 2016 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K161359 | 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System | Jul 19, 2016 | Substantially Equivalent | Esaote S.p.A |
| K161525 | TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System | Jul 13, 2016 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
| K160853 | Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging System | Jun 27, 2016 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD (SIUI) |
| K161119 | SonoSite iViz Ultrasound System | May 13, 2016 | Substantially Equivalent | FUJIFILM SONOSITE,INC. |
| K161047 | LOGIQ P9 and LOGIQ P7 | May 05, 2016 | Substantially Equivalent | GE Healthcare |
| K153277 | 6200 Ultrasound System and 6250 Ultrasound System | May 04, 2016 | Substantially Equivalent | Esaote S.p.A. |
| K160357 | TRINITY | May 02, 2016 | Substantially Equivalent | KOELIS |
| K160162 | Voluson P6, Voluson P8 | Apr 26, 2016 | Substantially Equivalent | GE HEALTHCARE |
| K160674 | Fujifilm Sonosite Vevo MD Imaging System | Apr 19, 2016 | Substantially Equivalent | FUJIFILM SONOSITE, INC. |
| K160343 | SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner | Apr 07, 2016 | Substantially Equivalent | BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD |
| K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System | Apr 06, 2016 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K160734 | SonoSite SII Ultrasound System | Apr 05, 2016 | Substantially Equivalent | FUJIFILM SonoSite, Inc. |
| K160790 | Acclarix LX8 Diagnostic Ultrasound System | Apr 04, 2016 | Substantially Equivalent | Edan Instruments Inc |
| K160283 | S45 Digital Color Doppler Ultrasound System | Apr 04, 2016 | Substantially Equivalent | SONOSCAPE MEDICAL CORP. |
| K160258 | X5 Digital Color Doppler Ultrasound System | Apr 01, 2016 | Substantially Equivalent | SONOSCAPE MEDICAL CORP. |
| K160277 | LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 | Mar 25, 2016 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K160406 | FUJIFILM FC1 Ultrasound System | Mar 16, 2016 | Substantially Equivalent | FUJIFILM SonoSite, Inc. |
| K160078 | Vivid T8 | Mar 10, 2016 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnotics, L |
| K160381 | TE7 Diagnostic Ultrasound System | Mar 09, 2016 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K160182 | LOGIQ S7 Expert | Feb 26, 2016 | Substantially Equivalent | GE Healthcare |
| K153424 | E-CUBE i7 | Feb 26, 2016 | Substantially Equivalent | ALPINION MEDICAL SYSTEMS CO., LTD. |
| K160184 | Voluson S6, Voluson S8, Voluson S10 | Feb 25, 2016 | Substantially Equivalent | GE HEALTHCARE |
| K153529 | WS80A Diagnostic Ultrasound System | Feb 02, 2016 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD. |
| K153421 | HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS | Jan 21, 2016 | Substantially Equivalent | HITACHI ALOKA MEDICAL AMERICA, INC. |
| K153626 | SonoSite Edge II Ultrasound System | Jan 20, 2016 | Substantially Equivalent | FUJIFILM SONOSITE,INC. |
| K152854 | S50 Digital Color Doppler Ultrasound System | Jan 13, 2016 | Substantially Equivalent | SONOSCAPE MEDICAL CORP. |
| K153037 | LOGIQ V1/ LOGIQ V2 | Jan 04, 2016 | Substantially Equivalent | GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC |
| K153408 | HM70A Diagnostic Ultrasound System | Dec 21, 2015 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD |
| K153085 | Q Series Diagnostic Ultrasound System | Dec 21, 2015 | Substantially Equivalent | CHISON MEDICAL IMAGING CO., LTD. |
| K153480 | ClearVue850 Diagnostic Ultrasound System | Dec 16, 2015 | Substantially Equivalent | PHILIPS HEALTHCARE |
| K152467 | Touch Ultrasound | Dec 09, 2015 | Substantially Equivalent | CARESTREAM HEALTH, INC. |
| K152758 | Venue 50 | Nov 18, 2015 | Substantially Equivalent | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS |
| K152983 | FUJIFILM SonoSite iViz Ultrasound System | Nov 12, 2015 | Substantially Equivalent | FUJIFILM SONOSITE,INC. |
| K152567 | Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System | Nov 06, 2015 | Substantially Equivalent | GE Healthcare |
| K152962 | HS70A Diagnostic Ultrasound System | Nov 02, 2015 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD. |
| K152899 | Philips Lumify Diagnostic Ultrasound System | Oct 30, 2015 | Substantially Equivalent | PHILIPS HEALTHCARE, INC. |
| K152543 | M9/M9CV/M9T Diagnostic Ultrasound System | Oct 29, 2015 | Substantially Equivalent | Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
| K152763 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System | Oct 21, 2015 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K152577 | ULTRASOUND SYSTEM SONIMAGE HS 1 | Oct 08, 2015 | Substantially Equivalent | KONICA MINOLTA, INC. |
| K152369 | ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System | Oct 06, 2015 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS, USA, INC. ULTRASOUND GROUP |
| K151910 | Ultrasound Scanner System BK2300 | Oct 05, 2015 | Substantially Equivalent | BK MEDICAL APS |
| K152545 | DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems | Oct 02, 2015 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K152195 | LOGIQ S8 | Sep 29, 2015 | Substantially Equivalent | GE Healthcare |
| K152469 | ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System | Sep 21, 2015 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS, INC., ULTRASOUND DIVISION |
| K152052 | Ultrasound Scanner System bk2300 | Sep 16, 2015 | Substantially Equivalent | BK MEDICAL APS |
| K152309 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | Sep 14, 2015 | Substantially Equivalent | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS |
| K152396 | S12 Digital Color Doppler Ultrasound System | Sep 03, 2015 | Substantially Equivalent | SONOSCAPE MEDICAL CORP. |
| K152250 | SpeqRT | Sep 03, 2015 | Substantially Equivalent | Signostics Limited |
| K142982 | OPUS 5100 Diagnostic Doppler Ultrasound System | Sep 03, 2015 | Substantially Equivalent | Chang Gung Medical Technology Co., Ltd. |
| K152164 | S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System | Aug 28, 2015 | Substantially Equivalent | SONOSCAPE MEDICAL CORP. |
| K152165 | S9 Portable Digital Color Doppler Ultrasound System | Aug 26, 2015 | Substantially Equivalent | SONOSCAPE MEDICAL CORP. |
| K152209 | FUJIFILM SonoSite X-Porte Ultrasound System | Aug 19, 2015 | Substantially Equivalent | FUJIFILM SONOSITE,INC. |
| K151663 | RS80A Diagnostic Ultrasound System | Aug 12, 2015 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD. |
| K150861 | QBit Series Diagnostic Ultrasound System | Jul 28, 2015 | Substantially Equivalent | CHISON MEDICAL IMAGING CO., LTD. |
| K150773 | E-CUBE 15 Diagnostic Ultrasound System | Jul 23, 2015 | Substantially Equivalent | ALPINION MEDICAL SYSTEMS CO., LTD |
| K141720 | iuStar300 Medical Ultrasound Diagnostic System | Jul 23, 2015 | Substantially Equivalent | UNITED IMAGING SYSTEMS (BEIJING) CO., LTD. |
| K151451 | Aplio 500/400/300 Diagnostic Ultrasound System V6.0 | Jul 09, 2015 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K150002 | iNSIGHT Color Doppler Ultrasound System | Jun 23, 2015 | Substantially Equivalent | SASET (CHENGDU) INC. |
| K143476 | Digi-One | Jun 23, 2015 | Substantially Equivalent | RIMED LTD. |
| K151028 | LOGIQ e | Jun 18, 2015 | Substantially Equivalent | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS |
| K150080 | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S | Jun 12, 2015 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K150628 | VentriPoint Medical System | May 22, 2015 | Substantially Equivalent | VENTRIPOINT, INC. |
| K151175 | ZONARE ZS3 Diagnostic Ultrasound System | May 15, 2015 | Substantially Equivalent | ZONARE MEDICAL SYSTEMS, INC. |
| K150533 | Terason uSmart3200T Ultrasound System | May 09, 2015 | Substantially Equivalent | TERATECH CORP. |
| K150045 | S30/S40 Digital Color Doppler Ultraound System | Apr 28, 2015 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K150204 | DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems | Apr 10, 2015 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K150478 | A35 Diagnostic Ultrasound System | Mar 26, 2015 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD. |
| K143601 | U-Lite | Mar 18, 2015 | Substantially Equivalent | Sonoscanner SARL |
| K150249 | ZONARE ZS3 and Z.Onepro Diagnostic Ultrasound System | Mar 04, 2015 | Substantially Equivalent | ZONARE MEDICAL SYSTEMS, INC. |
| K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System | Mar 04, 2015 | Substantially Equivalent | GE VINGMED ULTRASOUND AS |
| K150148 | Terason uSmart3300 Ultrasound System | Feb 20, 2015 | Substantially Equivalent | TERATECH CORP. |
| K142511 | U50 Diagnostic Ultrasound System | Feb 20, 2015 | Substantially Equivalent | EDAN INSTRUMENTS, INC. |
| K142472 | Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems | Feb 10, 2015 | Substantially Equivalent | GE Healthcare |
| K150050 | ACUSON P500 Diagnostic Ultrasound System | Feb 09, 2015 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K143452 | LOGIQ P9, LOGIQ P7 | Jan 29, 2015 | Substantially Equivalent | GE HEALTHCARE |
| K142714 | S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System | Jan 29, 2015 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K142815 | S22 Digital Color Doppler Ultrasound System | Jan 28, 2015 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K143298 | Ultrasound Scanner System bk2300 | Jan 16, 2015 | Substantially Equivalent | BK MEDICAL APS |
| K142368 | NOBLUS DIAGNOSTIC ULTRASOUND SCANNER | Jan 14, 2015 | Substantially Equivalent | HITACHI ALOKA MEDICAL, LTD. |
| K142710 | S9 Portable Digital Color Doppler Ultrasound System | Jan 05, 2015 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K143472 | TE7 Diagnostic Ultrasound System | Jan 02, 2015 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K142474 | S12 Digital Color Doppler Ultrasound System | Dec 19, 2014 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K143264 | H60 V2.00 Diagnostic Ultrasound System | Dec 09, 2014 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD |
| K143089 | WS80A Diagnostic Ultrasound System | Nov 26, 2014 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD |
| K142197 | ULTRASOUND SYSTEM SONIMAGE HS1, LINEAR PROBE L18-4, CONVEX PROBE C5-2 | Nov 21, 2014 | Substantially Equivalent | KONICA MINOLTA INC. |
| K143027 | Xario 200, V3.0 | Nov 20, 2014 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K142100 | AIXPLORER | Nov 20, 2014 | Substantially Equivalent | SUPERSONIC IMAGINE |
| K143046 | Xario 100, V3.0 | Nov 19, 2014 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K141462 | VARIA-NCI | Nov 19, 2014 | Substantially Equivalent | NEUROCHAOS SOLUTIONS, INC. |
| K131973 | UNEXEF-38G ULTRASOUND SYSTEM | Nov 18, 2014 | Substantially Equivalent | TOYOTA TSUSHO CORPORATION |
| K142884 | E-CUBE 12 | Oct 28, 2014 | Substantially Equivalent | ALPINION MEDICAL SYSTEMS CO., LTD |
| K142733 | E-CUBE 5 | Oct 28, 2014 | Substantially Equivalent | ALPINION MEDICAL SYSTEMS CO., LTD |
| K141459 | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0 | Oct 28, 2014 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K142876 | ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems | Oct 23, 2014 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K142628 | Acuson SC2000 Diagnostic Ultrasound System | Oct 10, 2014 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS, INC. |
| K142323 | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System | Oct 10, 2014 | Substantially Equivalent | GE MEDICAL SYSTEMS ISRAEL LTD. |
| K142160 | LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM | Oct 10, 2014 | Substantially Equivalent | GE HEALTHCARE |
| K142466 | UGEO PT60A Diagnostic Ultrasound System | Oct 03, 2014 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD |
| K142077 | MYLABGAMMA | Sep 12, 2014 | Substantially Equivalent | ESAOTE, S.P.A. |
| K142008 | MYLABSEVEN, MYLABALPHA | Sep 12, 2014 | Substantially Equivalent | ESAOTE S.P.A. |
| K142017 | X-PORTE ULTRASOUND SYSTEM | Aug 22, 2014 | Substantially Equivalent | FUJIFILM SonoSite, Inc. |
| K141870 | BREAST VOLUME NAVIGATOR | Aug 07, 2014 | Substantially Equivalent | METRITRACK LLC |
| K141846 | ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM | Aug 07, 2014 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K141768 | LOGIQ V5/LOGIQ V3 | Aug 04, 2014 | Substantially Equivalent | GE HEALTHCARE |
| K141675 | VOLUSON P6, VOLUSON P8 | Jul 25, 2014 | Substantially Equivalent | GE HEALTHCARE |
| K141641 | ZONARE ZS3 DIAGNOSTIC ULTRASOUND SYSTEM | Jul 18, 2014 | Substantially Equivalent | ZONARE MEDICAL SYSTEMS, INC. |
| K141639 | VOLUSON S6, VOLUSON S8 | Jul 18, 2014 | Substantially Equivalent | GE HEALTHCARE |
| K141486 | MYLABSIX ULTRASOUND SYSTEM | Jul 11, 2014 | Substantially Equivalent | ESAOTE EUROPE B.V. |
| K141620 | RS80A DIAGNOSTIC ULTRASOUND SYSTEM | Jul 02, 2014 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD |
| K141369 | VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM | Jul 02, 2014 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K140443 | ARIETTA 60/ARIETTAS60/ARIETTAV60 | Jun 16, 2014 | Substantially Equivalent | HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL |
| K141261 | LOGIQ S7 EXPERT, LOGIQ S7 PRO | Jun 05, 2014 | Substantially Equivalent | GE HEALTHCARE |
| K140364 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED AND CONVEX PROBE, PENCIL AND CONVEX PROBE | Jun 02, 2014 | Substantially Equivalent | CHISON MEDICAL IMAGING CO., LTD. |
| K140773 | TERASON USMART3300 ULTRASOUND SYSTEM | May 30, 2014 | Substantially Equivalent | TERATECH CORP. |
| K141067 | VIVID T8/VIVID T8 PRO | May 23, 2014 | Substantially Equivalent | GE HEALTHCARE |
| K140729 | APLIO ARTIDA, V3.2 | May 23, 2014 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K140693 | VSCAN WITH DUAL PROBE | May 16, 2014 | Substantially Equivalent | GE MEDICAL SYSYEMS ULTRASOUND & PRIMARY CARE DIAGN |
| K141010 | M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM | May 14, 2014 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS., CO. LTD |
| K140959 | ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS | Apr 30, 2014 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K140834 | TERASON USMART3400 ULTRASOUND SYSTEM | Apr 25, 2014 | Substantially Equivalent | TERATECH CORP. |
| K140677 | MYLABSSOGNO | Apr 25, 2014 | Substantially Equivalent | ESAOTE S.P.A. |
| K133761 | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0 | Apr 22, 2014 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K140639 | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | Apr 16, 2014 | Substantially Equivalent | HITACHI ALOKA MEDICAL, LTD. |
| K133905 | 6200 / 6250 ULTRASOUND SYSTEM | Apr 15, 2014 | Substantially Equivalent | ESAOTE S.P.A. |
| K134016 | ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER | Mar 28, 2014 | Substantially Equivalent | HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL |
| K140524 | TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM | Mar 21, 2014 | Substantially Equivalent | TERATECH CORP. |
| K140153 | VENTRIPOINT MEDICAL SYSTEM | Mar 06, 2014 | Substantially Equivalent | VENTRIPOINT, INC. |
| K140254 | EZONO 4000 | Feb 26, 2014 | Substantially Equivalent | EZONO AG |
| K132690 | UP600 DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM | Feb 25, 2014 | Substantially Equivalent | QISDA CORPORATION |
| K140030 | DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM | Feb 19, 2014 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K133533 | LOGIQ E | Feb 12, 2014 | Substantially Equivalent | GE HEALTHCARE |
| K133034 | LOGIQ F SERIES | Jan 31, 2014 | Substantially Equivalent | GE HEALTHCARE |
| K133833 | NUVIS DIAGNOSTIC ULTRASOUND SYSTEM | Jan 17, 2014 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K133277 | XARIO 100 | Jan 17, 2014 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K132335 | ULTRASOUND SCANNER FLEX FOCUS 1202 | Jan 10, 2014 | Substantially Equivalent | B-K MEDICAL APS |
| K132677 | ULTRASOUND SCANNER FLEX FOCUS 1202 | Jan 07, 2014 | Substantially Equivalent | B-K MEDICAL APS |
| K132685 | ULTRASOUND SCANNER PRO FOCUS 2202 | Jan 06, 2014 | Substantially Equivalent | B-K MEDICAL APS |
| K133505 | SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 27, 2013 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD |
| K133431 | VENUE 50 | Dec 24, 2013 | Substantially Equivalent | GE HEALTHCARE |
| K131164 | ACUSON | Dec 24, 2013 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K133454 | SONOSITE EDGE ULTRASOUND SYSTEM | Dec 16, 2013 | Substantially Equivalent | FUJIFILM SONOSITE,INC. |
| K132466 | MYLABSEVEN 6400, MYLABALPHA 7400 | Dec 04, 2013 | Substantially Equivalent | ESAOTE S.P.A. |
| K133329 | UGEO WS80A DIAGNOSTIC ULTRASOUND SYSTEM | Nov 27, 2013 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD |
| K132687 | E-CUBE 7 | Nov 27, 2013 | Substantially Equivalent | ALPINION MEDICAL SYSTEMS CO., LTD |
| K132231 | MYLABSEVEN, MYLABALPHA | Nov 27, 2013 | Substantially Equivalent | ESAOTE, S.P.A. |
| K132779 | DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM | Nov 19, 2013 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K132527 | DIGITAL COLOR DOPPLER ULTASOUND SYSTEM | Nov 14, 2013 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K132913 | VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 | Nov 08, 2013 | Substantially Equivalent | GE HEALTHCARE |
| K133134 | X-PORTE ULTRASOUND SYSTEM | Nov 04, 2013 | Substantially Equivalent | FUJIFILM SONOSITE,INC. |
| K132059 | DIAGNOSTIC ULTRASOUND SYSTEM | Oct 25, 2013 | Substantially Equivalent | ADVANCED INSTRUMENTATIONS, INC. |
| K132804 | ACUSON S1000 / S2000 / S3000 | Oct 24, 2013 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GRO |
| K132942 | SITE-RITE VISION II ULTRASOUND SYSTEM | Oct 17, 2013 | Substantially Equivalent | C.R. BARD, INC. |
| K130881 | ACUSON S2000 AND S3000 | Oct 11, 2013 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K132861 | UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM | Oct 04, 2013 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD |
| K132768 | S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | Oct 04, 2013 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K132274 | AIXPLORER | Sep 24, 2013 | Substantially Equivalent | SUPERSONIC IMAGINE |
| K132171 | AIXPLORER | Sep 24, 2013 | Substantially Equivalent | SUPERSONIC IMAGINE |
| K131937 | VOLUSON I/E | Sep 24, 2013 | Substantially Equivalent | GE HEALTHCARE |
| K131507 | XARIO 200 DIAGNOSTIC ULTRASOUND SYSTEM | Aug 28, 2013 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K131527 | LOGIQ S8 | Aug 26, 2013 | Substantially Equivalent | GE HEALTHCARE |
| K132304 | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM | Aug 21, 2013 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K132341 | DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS | Aug 15, 2013 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K131305 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE | Aug 01, 2013 | Substantially Equivalent | CHISON MEDICAL IMAGING CO., LTD. |
| K131514 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Jul 12, 2013 | Substantially Equivalent | GE VINGMED ULTRASOUND AS |
| K131213 | DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | Jun 21, 2013 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K130833 | DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM; DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Jun 21, 2013 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K131267 | VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10 | Jun 19, 2013 | Substantially Equivalent | GE HEALTHCARE |
| K130695 | Z5 DIAGNOSTIC ULTRASOUND SYSTEM | Jun 19, 2013 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K130499 | IU22 DIAGNOSTIC ULTRASOUND SYSTEM | Jun 18, 2013 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K130801 | DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | Jun 14, 2013 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K130739 | ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS | Jun 06, 2013 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K131209 | TERASON USMART3200T ULTRASOUND SYSTEM | May 24, 2013 | Substantially Equivalent | TERATECH CORP. |
| K131088 | PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | May 24, 2013 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K130803 | UGEO H70C DIAGNOSTIC ULTRASOUND SYSTEM | Apr 12, 2013 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD |
| K130119 | PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | Apr 12, 2013 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K122537 | PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0 | Apr 12, 2013 | Substantially Equivalent | HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL |
| K130308 | NOBLUS ULTRASOUND DIAGNOSTIC SYSTEM | Apr 05, 2013 | Substantially Equivalent | HITACHI ALOKA MEDICAL, LTD. |
| K130659 | SPEQRT ULTRASOUND SYSTEM | Apr 03, 2013 | Substantially Equivalent | SIGNOSTICS PTY LTD |
| K130754 | ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | Mar 25, 2013 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS, INC. |
| K130173 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | Mar 25, 2013 | Substantially Equivalent | FUJIFILM SONOSITE,INC. |
| K130619 | ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM | Mar 21, 2013 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K130058 | ENDOSCOPIC ULTRASOUND CENTER EU-Y0008 | Feb 22, 2013 | Substantially Equivalent | OLYMPUS MEDICAL SYSTEMS CORP. |
| K122710 | TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND | Feb 15, 2013 | Substantially Equivalent | SHENZHEN DELICATE ELECTRONICS CO., LTD. |
| K123254 | ULTRASOUND SCANNER FLEX FOCUS | Feb 13, 2013 | Substantially Equivalent | B-K MEDICAL APS |
| K123249 | DIAGNOSTIC ULTRASOUND SYSTEM | Feb 08, 2013 | Substantially Equivalent | EDAN INSTRUMENTS, INC. |
| K123992 | APLIO 500/400/300 V3.0 | Feb 06, 2013 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K123610 | E-CUBE 15 | Feb 01, 2013 | Substantially Equivalent | ALPINION MEDICAL SYSTEMS CO., LTD |
| K123828 | PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | Jan 18, 2013 | Substantially Equivalent | HITACHI ALOKA MEDICAL, LTD. |
| K123754 | CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 21, 2012 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K123611 | E-CUBE 7 | Dec 21, 2012 | Substantially Equivalent | ALPINION MEDICAL SYSTEMS CO., LTD |
| K123564 | LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 18, 2012 | Substantially Equivalent | GE HEALTHCARE |
| K123565 | PRESTO 1000 SYSTEM | Dec 13, 2012 | Substantially Equivalent | PHYSIOSONICS, INC |
| K123503 | DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 13, 2012 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K123622 | ACUSON | Dec 05, 2012 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA INC. |
| K123001 | ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM | Oct 26, 2012 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K121564 | ENDOSCOPIC ULTRASOUND CENTER EU-Y0006 | Oct 16, 2012 | Substantially Equivalent | OLYMPUS MEDICAL SYSTEMS CORP. |
| K122114 | LOGIQ S7 EXPERT, LOGIQ S7 PRO | Oct 03, 2012 | Substantially Equivalent | GE HEALTHCARE |
| K122009 | AIDA VI.8 DIAGNOSTIC ULTRASOUND GM-72P00A, L13-5V1 TRANSDUCER | Oct 03, 2012 | Substantially Equivalent | PANASONIC HEALTHCARE CO., LTD. |
| K122825 | ACUSON | Sep 28, 2012 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K122341 | PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 | Sep 26, 2012 | Substantially Equivalent | HITACHI ALOKA MEDICAL, LTD. |
| K122327 | VOLUSON E6/E8/E8EXPERT/E10 | Sep 21, 2012 | Substantially Equivalent | GE HEALTHCARE |
| K121729 | E-CUBE 7 | Sep 20, 2012 | Substantially Equivalent | ALPINION MEDICAL SYSTEMS CO., LTD |
| K122491 | VIAMO SSA-640A V4.0 | Sep 13, 2012 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K122387 | VOLUSON P6, VOLUSON P8 | Sep 11, 2012 | Substantially Equivalent | GE HEALTHCARE |
| K121983 | DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA | Sep 07, 2012 | Substantially Equivalent | BENQ MEDICAL TECHNOLOGY CORPATION |
| K122583 | UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM | Sep 05, 2012 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD |
| K112255 | AIXPLORER | Aug 28, 2012 | Substantially Equivalent | SUPERSONIC IMAGINE |
| K121329 | AIXPLORER | Aug 24, 2012 | Substantially Equivalent | SUPERSONIC IMAGINE |
| K121063 | VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM | Aug 21, 2012 | Substantially Equivalent | GE MEDICAL SYSTEM ISRAEL LTD. |
| K121867 | SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS | Aug 02, 2012 | Substantially Equivalent | CHISON MEDICAL IMAGING CO., LTD. |
| K121937 | E-CUBE INNO | Jul 26, 2012 | Substantially Equivalent | ALPINION MEDICAL SYSTEMS CO., LTD |
| K122010 | Z6 DIAGNOSTIC ULTRASOUND SYSTEM | Jul 20, 2012 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K121699 | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM | Jun 22, 2012 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K121646 | ACUSON X150 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X150 DIAGNOSTIC ULTRASOUND SYSTEM | Jun 22, 2012 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GRO |
| K121577 | APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM | Jun 22, 2012 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
| K113613 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM | Jun 15, 2012 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
| K120801 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM | Jun 14, 2012 | Substantially Equivalent | CHISON MEDICAL IMAGING CO., LTD. |
| K121384 | MYLABSOGNO | May 23, 2012 | Substantially Equivalent | ESAOTE, S.P.A. |
| K121138 | ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM | May 17, 2012 | Substantially Equivalent | SIEMENS MEDICAL SOLUTION |
| K120741 | VOLUSON S6, VOLUSON S8 | Apr 27, 2012 | Substantially Equivalent | GE HEALTHCARE |
| K121010 | M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM | Apr 19, 2012 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K120699 | DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM | Apr 19, 2012 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K120234 | EZONO 3000 | Apr 19, 2012 | Substantially Equivalent | LIFE-TECH, INC. |
| K120703 | ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM | Apr 13, 2012 | Substantially Equivalent | ZONARE MEDICAL SYSTEMS, INC. |
| K120060 | E-CUBE 9 | Mar 16, 2012 | Substantially Equivalent | ALPINION MEDICAL SYSTEMS CO., LTD |
| K120321 | CLEARVUE 350/550 DIAGNOSTIC ULTRASOUND SYSTEM | Feb 17, 2012 | Substantially Equivalent | PHILIPS HEALTHCARE |
| K113612 | AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A | Feb 10, 2012 | Substantially Equivalent | PANASONIC HEALTHCARE CO., LTD. |
| K113359 | CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE | Feb 03, 2012 | Substantially Equivalent | CHISON MEDICAL IMAGING CO., LTD. |
| K112953 | TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS | Feb 03, 2012 | Substantially Equivalent | TERATECH CORP. |
| K113184 | LOGICSCAN 64 LOGICSCAN 128 | Jan 26, 2012 | Substantially Equivalent | TELEMED |
| K113663 | SONIXTABLET ULTRASOUND SCANNER | Jan 25, 2012 | Substantially Equivalent | UltraSonix Medical Corporation |
| K113690 | GE LOGIQ I, LOGIQ E AND VIVID E | Dec 29, 2011 | Substantially Equivalent | GE HEALTHCARE |
| K113381 | MYSONO U6 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 29, 2011 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD |
| K112997 | HD-IVUS ULTRASOUND IMAGING SYSTEM | Dec 17, 2011 | Substantially Equivalent | SILICON VALLY MEDICAL INSTRUMENTS, INC. |
| K113647 | DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM | Dec 16, 2011 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K100919 | PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 | Dec 16, 2011 | Substantially Equivalent | B-K MEDICAL APS |
| K113179 | ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 07, 2011 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
| K112602 | S6 DIAGNOSTIC ULTRASOUND SYSTEM | Nov 07, 2011 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K112646 | SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM | Oct 12, 2011 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD |
| K110870 | APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM; APLIO DIAGNOSTIC ULTRASOUND SYSTEM | Oct 04, 2011 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K112726 | SONIX ULTRASOUND SCANNER | Sep 27, 2011 | Substantially Equivalent | UltraSonix Medical Corporation |
| K112371 | LOGIQ P3 | Sep 27, 2011 | Substantially Equivalent | GE HEALTHCARE |
| K110673 | HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER | Sep 27, 2011 | Substantially Equivalent | HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K112122 | VENUE 40 | Sep 23, 2011 | Substantially Equivalent | GE HEALTHCARE |
| K112596 | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM | Sep 16, 2011 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
| K112451 | S8 DIAGNOSTIC ULTRASOUND SYSTEM | Sep 16, 2011 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K112213 | VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM | Sep 01, 2011 | Substantially Equivalent | GE HEALTHCARE |
| K112339 | ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM | Aug 29, 2011 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD |
| K111582 | LOGIQ S8 | Jul 26, 2011 | Substantially Equivalent | GE HEALTHCARE |
| K111302 | MYLABSEVEN, MYLABALPHA | Jul 22, 2011 | Substantially Equivalent | ESAOTE, S.P.A. |
| K110943 | LOGIQ E9 | Jul 22, 2011 | Substantially Equivalent | GE HEALTHCARE |
| K111864 | E-CUBE 9 | Jul 15, 2011 | Substantially Equivalent | ALPINION MEDICAL SYSTEMS CO., LTD |
| K111674 | ACUSON | Jun 30, 2011 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K102813 | EZONO 3000 | Jun 30, 2011 | Substantially Equivalent | LIFE-TECH, INC. |
| K111513 | CX50 DIAGNOSTIC ULTRASOUND SYSTEM | Jun 24, 2011 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K110510 | S20 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM | May 16, 2011 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K111227 | ALOKA SSD-3500 DIAGNOSTIC ULTRASOUND SYSTEM | May 13, 2011 | Substantially Equivalent | ALOKA CO., LTD. |
| K110841 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER | Apr 15, 2011 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
| K110482 | PROSOUND C3 / C3 CV ULTRASOUND SYSTEMS | Mar 18, 2011 | Substantially Equivalent | TERATECH CORP. |
| K103471 | UBM PLUS | Mar 14, 2011 | Substantially Equivalent | ACCUTOME, INC. |
| K103649 | VOLUSON S6, VOLUSON S8 | Mar 09, 2011 | Substantially Equivalent | GE HEALTHCARE |
| K102642 | SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY, 5P1 PHASED ARRAY MODEL 2P1, 5P1, 6V1 MICRO | Mar 04, 2011 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K103397 | ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM | Feb 25, 2011 | Substantially Equivalent | MEDISON CO., LTD. |
| K110207 | ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM | Feb 17, 2011 | Substantially Equivalent | ALOKA CO., LTD. |
| K110199 | DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM | Feb 08, 2011 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K101236 | VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM | Feb 08, 2011 | Substantially Equivalent | GE HEALTHCARE |
| K101312 | NUVUE COLORMARK9TM) NEEDLE | Feb 04, 2011 | Substantially Equivalent | NU VUE THERAPEUTICS, INC |
| K103677 | M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM | Jan 31, 2011 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K103144 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM; CONVEX / LINEAR PHASED ARRAY TRANSDUCER | Jan 12, 2011 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
| K103152 | 6250 ULTRASOUND SYTEMS | Jan 07, 2011 | Substantially Equivalent | ESAOTE, S.P.A. |
| K103583 | DC-7 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 27, 2010 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K102997 | SONIXTABLET ULTRASOUND SCANNER | Dec 21, 2010 | Substantially Equivalent | UltraSonix Medical Corporation |
| K102989 | OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS | Dec 09, 2010 | Substantially Equivalent | CHANG GUNG MEDICAL TECHNOLOGY CO., LTD. LINKOU FAC |
| K102390 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | Nov 19, 2010 | Substantially Equivalent | SONOSITE,INC. |
| K100598 | PENRITH ELETTRA ULTRASOUND SYSTEM | Nov 19, 2010 | Substantially Equivalent | PENRITH CORPORATION |
| K102388 | VIVID I DIAGNOSTIC ULTRASOUND SYSTEM | Nov 04, 2010 | Substantially Equivalent | GE MEDICAL SYSTEM ISRAEL LTD. |
| K102901 | HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER | Oct 27, 2010 | Substantially Equivalent | HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K102023 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C | Oct 19, 2010 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
| K102256 | GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND | Oct 05, 2010 | Substantially Equivalent | GE MEDICAL SYSTEMS CHINA CO., LTD. |
| K101874 | GE LOGIQ P6/P6 PRO | Oct 05, 2010 | Substantially Equivalent | GE HEALTHCARE |
| K102104 | GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Oct 01, 2010 | Substantially Equivalent | WIPRO GE HEALTHCARE PRIVATE, LTD. |
| K102017 | SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | Sep 20, 2010 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K101878 | GE LOGIQ P5 MODEL H44662LD | Aug 31, 2010 | Substantially Equivalent | GE HEALTHCARE |
| K101605 | MYLABONE ULTRASOUND SYSTEM | Aug 31, 2010 | Substantially Equivalent | ESAOTE EUROPE B.V. |
| K102113 | GE VENUE 40 COMPACT DIAGNOSTIC ULTRASOUND | Aug 12, 2010 | Substantially Equivalent | GE MEDICAL SYSTEMS CHINA CO., LTD. |
| K102065 | SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM | Aug 06, 2010 | Substantially Equivalent | MEDISON CO., LTD. |
| K101455 | EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM | Jul 19, 2010 | Substantially Equivalent | MEDISON CO., LTD. |
| K101091 | Z.ONE ULTRA ULTRASOUND SYSTEM | Jun 25, 2010 | Substantially Equivalent | ZONARE MEDICAL SYSTEMS, INC. |
| K100989 | ZURA TEE SYSTEM WITH CLARITEE PROBE | Jun 25, 2010 | Substantially Equivalent | IMACOR INC. |
| K100931 | MYLABTWICE, MODEL 6200 | Jun 25, 2010 | Substantially Equivalent | ESAOTE, S.P.A. |
| K093395 | OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE | Jun 17, 2010 | Substantially Equivalent | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| K100830 | M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM | May 05, 2010 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K100186 | MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM | Mar 24, 2010 | Substantially Equivalent | MEDISON CO., LTD. |
| K092922 | SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER | Mar 12, 2010 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K100402 | SITE-RITE VISION ULTRASOUND SYSTEM | Mar 05, 2010 | Substantially Equivalent | BARD ACCESS SYSTEMS, INC. |
| K092907 | DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR | Mar 05, 2010 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
| K093812 | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM | Mar 03, 2010 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K093563 | IU22 ULTRASOUND SYSTEM AND TRANSDUCERS | Feb 01, 2010 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K093849 | ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM | Jan 19, 2010 | Substantially Equivalent | MEDISON CO., LTD. |
| K093613 | VASCUVIEW TAP ULTRASOUND SYSTEM | Dec 23, 2009 | Substantially Equivalent | ESCALON MEDICAL CORP. |
| K093171 | VIAMO SSA-640A VERSION 1.2 | Dec 04, 2009 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K093531 | ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 01, 2009 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS, INC. |
| K092271 | GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4 | Nov 17, 2009 | Substantially Equivalent | GE HEALTHCARE |
| K092948 | APLIO MX SSA-780A, VERSION 1.0 | Oct 09, 2009 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K092058 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM | Oct 02, 2009 | Substantially Equivalent | SONOSITE,INC. |
| K091970 | AIXPLORER ULTRASOUND SYSTEM | Aug 12, 2009 | Substantially Equivalent | SUPERSONIC IMAGINE |
| K092079 | MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND | Aug 06, 2009 | Substantially Equivalent | GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. |
| K092179 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001 | Jul 29, 2009 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K092159 | ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM | Jul 28, 2009 | Substantially Equivalent | MEDISON CO., LTD. |
| K091009 | MY LABS25 GOLD/MYLAB30 GOLD CARDIOVASCULAR MODEL 7340, MY LAB70/MY LAB70XVISION/MYLAB60, MODEL 6150 | May 18, 2009 | Substantially Equivalent | ESAOTE S.P.A. |
| K091164 | GE VENUE 40, MODEL 5324338 | May 05, 2009 | Substantially Equivalent | GE MEDICAL SYSTEMS CHINA CO., LTD. |
| K090743 | YIELD MINI DOPPLER SYSTEM | Apr 03, 2009 | Substantially Equivalent | BRONCUS TECHNOLOGIES, INC. |
| K083114 | ACUSON P50 ULTRASOUND SYSTEM | Mar 31, 2009 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K090229 | DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM 2-5MHZ CURVED LINEAR ARRAY, 5-10MHZ LINEAR ARRAY, 2-4MHZ PHASE ARRAY, 4-8MHZ TRANSV | Mar 13, 2009 | Substantially Equivalent | CHANG GUNG MEDICAL SUPPLIES & EQUIPMENT CORP. |
| K090334 | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM | Feb 20, 2009 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS, INC. |
| K090158 | APLIO ARTIDA V2.0 SSH-880CV | Feb 06, 2009 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K083882 | MYLABFIVE | Jan 30, 2009 | Substantially Equivalent | ESAOTE EUROPE B.V. |
| K083254 | ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 19, 2008 | Substantially Equivalent | ALOKA CO., LTD. |
| K083505 | DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM | Dec 12, 2008 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K082142 | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM | Nov 13, 2008 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
| K083095 | SONIXTOUCH ULTRASOUND SYSTEM | Oct 31, 2008 | Substantially Equivalent | UltraSonix Medical Corporation |
| K083001 | M5 DIAGNOSTIC ULTRASOUND SYSTEM | Oct 22, 2008 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K082326 | ZONARE ULTRA ULTRASOUND SYSTEM | Oct 08, 2008 | Substantially Equivalent | ZONARE MEDICAL SYSTEMS, INC. |
| K082656 | MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT | Sep 30, 2008 | Substantially Equivalent | FUKUDA DENSHI USA, INC. |
| K081386 | MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) | Sep 25, 2008 | Substantially Equivalent | ESAOTE S.P.A. |
| K082374 | VIVID I AND VIVID Q | Sep 02, 2008 | Substantially Equivalent | GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. |
| K082098 | SONOSITE MAXX SERIES ULTRASOUND SYSTEM | Aug 25, 2008 | Substantially Equivalent | SONOSITE,INC. |
| K082119 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0 | Aug 12, 2008 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K081921 | GE VIVID E9 ULTRASOUND | Aug 06, 2008 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K080935 | SONIX MDP ULTRASOUND SCANNER | Aug 06, 2008 | Substantially Equivalent | UltraSonix Medical Corporation |
| K081794 | MODEL 7340 ULTRASOUND SYSTEM | Jul 10, 2008 | Substantially Equivalent | ESAOTE, S.P.A. |
| K081676 | SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM | Jul 02, 2008 | Substantially Equivalent | MEDISON CO., LTD. |
| K081661 | HD15 DIAGNOSTIC ULTRASOUND SYSTEM | Jun 24, 2008 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K081065 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2 | Jun 06, 2008 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K081320 | DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM | May 27, 2008 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K080760 | ACUSON X300 ULTRASOUND SYSTEM | Apr 25, 2008 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
| K080800 | ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM | Apr 07, 2008 | Substantially Equivalent | MEDISON CO., LTD. |
| K080548 | HD7 DIAGNOSTIC ULTRASOUND SYSTEM | Mar 27, 2008 | Substantially Equivalent | PHILLIPS MEDICAL SYSTEMS |
| K080640 | M5 DIAGNOSTIC ULTRASOUND SYSTEM | Mar 21, 2008 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K073709 | MODIFICATION TO VIEWMATE SYSTEM | Mar 11, 2008 | Substantially Equivalent | EP MEDSYSTEMS |
| K080176 | ALOKA PROSOUND 6 DIAGNOSTIC ULTRASOUND SYSTEM | Feb 29, 2008 | Substantially Equivalent | ALOKA CO., LTD. |
| K080160 | APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM | Feb 08, 2008 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K073408 | GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 19, 2007 | Substantially Equivalent | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
| K073297 | GE LOGIQ P6 | Dec 18, 2007 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K072365 | SEQUOIA PLUS DIAGNOSTIC ULTRASOUND SYSTEM | Oct 17, 2007 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
| K072090 | SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS | Sep 14, 2007 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
| K072075 | MODIFICATION TO GE LOGIQ A3 | Aug 29, 2007 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K071985 | GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND | Aug 17, 2007 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K072000 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0 | Jul 30, 2007 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K071036 | MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM | May 16, 2007 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
| K070813 | ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM | Apr 10, 2007 | Substantially Equivalent | MEDISON CO., LTD. |
| K070576 | ACUSON X150 ULTRASOUND SYSTEM | Mar 26, 2007 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K063683 | OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC GASTROVIDEOSCOPE | Feb 08, 2007 | Substantially Equivalent | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| K063803 | ACUSON ANTARES DIAGNOSTIC ULTRASOUND SYSTEM | Jan 05, 2007 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
| K063761 | ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM | Jan 04, 2007 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K063518 | HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER | Dec 21, 2006 | Substantially Equivalent | HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K063493 | I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0 | Dec 21, 2006 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K063580 | SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 14, 2006 | Substantially Equivalent | MEDISON CO., LTD. |
| K063500 | DC-6 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 06, 2006 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K063138 | MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM | Nov 22, 2006 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K061608 | MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER | Nov 22, 2006 | Substantially Equivalent | HITACHI MEDICAL CORP. |
| K060421 | SONARA; SONARA/TEK | Nov 03, 2006 | Substantially Equivalent | VIASYS HEALTHCARE, INC. |
| K063130 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 | Nov 02, 2006 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K062578 | DIGI-LITE TCD DEVICE | Sep 18, 2006 | Substantially Equivalent | RIMED LTD. |
| K062247 | HD11 DIAGNOSTIC ULTRASOUND SYSTEM | Aug 18, 2006 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K061980 | SIEMENS ACUSON X500 ULTRASOUND SYSTEM | Aug 17, 2006 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA INC. |
| K061831 | MEDCHANNEL HTS SYSTEM | Aug 07, 2006 | Substantially Equivalent | MEDCHANNEL, LLC |
| K061827 | SONIX ULTRASOUND SCANNER | Aug 04, 2006 | Substantially Equivalent | UltraSonix Medical Corporation |
| K061643 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | Jul 27, 2006 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K061637 | ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO | Jul 25, 2006 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K061946 | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM | Jul 21, 2006 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K061525 | GE VIVID - I | Jul 03, 2006 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K061488 | CTS-5500/CTS-6600 ULTRASONIC PULSED ECHO IMAGING SYSTEM | Jun 30, 2006 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
| K061605 | NEMIO XG, SAA-580A | Jun 22, 2006 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K061437 | SIGMA 5000 SERIES, IMAGIC | Jun 14, 2006 | Substantially Equivalent | KONTRON MEDICAL SYSTEMS SAS |
| K061129 | GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000 | Jun 01, 2006 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K060827 | MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7350, 6150, 6100 | May 19, 2006 | Substantially Equivalent | ESAOTE, S.P.A. |
| K061213 | SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM | May 16, 2006 | Substantially Equivalent | MEDISON CO., LTD. |
| K060112 | NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM | May 05, 2006 | Substantially Equivalent | NODECREST LLC |
| K060993 | GE LOGIQ P5 AND A5 | May 03, 2006 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K060542 | GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX | Mar 31, 2006 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K060087 | ACCUVIX V7 DIAGNOSTIC ULTRASOUND SYSTEM | Jan 24, 2006 | Substantially Equivalent | MEDISON CO., LTD. |
| K053648 | PIONEER TC8080, COMPANION III | Jan 24, 2006 | Substantially Equivalent | VIASYS NEURO CARE |
| K060059 | ALOKA SD-3500 ULTRASOUND SYSTEM | Jan 13, 2006 | Substantially Equivalent | ALOKA CO., LTD. |
| K053530 | SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM | Jan 03, 2006 | Substantially Equivalent | MEDISON CO., LTD. |
| K053435 | GE VOLUSON I | Dec 16, 2005 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K053154 | MYLAB15/20 3D/4D ULTRASOUND IMAGING SYSTEM | Dec 16, 2005 | Substantially Equivalent | PIE MEDICAL |
| K053258 | EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER | Dec 09, 2005 | Substantially Equivalent | HITACHI MEDICAL CORP. |
| K052894 | SONOLINE G60 S ULTRASOUND SYSTEM | Nov 23, 2005 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K053084 | SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM | Nov 16, 2005 | Substantially Equivalent | KONTRON MEDICAL SYSTEMS SAS |
| K053069 | SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | Nov 16, 2005 | Substantially Equivalent | SONOSITE,INC. |
| K052331 | ACUSON CYPRESS ULTRASOUND SYSTEM | Nov 10, 2005 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K052911 | ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM | Oct 31, 2005 | Substantially Equivalent | MEDISON CO., LTD. |
| K052805 | MYLAB30, 50 AND 70 SYSTEMS UPGRADE, MODELS 7300, 7350, 6150 | Oct 17, 2005 | Substantially Equivalent | ESAOTE S.P.A. |
| K052410 | ACUSON SEQUOIA ULTRASOUND SYSTEM | Sep 22, 2005 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K052441 | GE LOGIQ 7 ULTRASOUND BT05 | Sep 21, 2005 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K052109 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES) | Aug 11, 2005 | Substantially Equivalent | SONOSITE,INC. |
| K052042 | SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS | Aug 09, 2005 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K051739 | POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB. | Jul 28, 2005 | Substantially Equivalent | MULTIGON INDUSTRIES, INC. |
| K051837 | MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100 | Jul 20, 2005 | Substantially Equivalent | ESAOTE, S.P.A. |
| K051449 | GE VIVID 7 WITH OR WITHOUT SUFFIX | Jun 16, 2005 | Substantially Equivalent | GE MEDICAL SYSTEMS |
| K051334 | TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER | Jun 03, 2005 | Substantially Equivalent | TERATECH CORP. |
| K051308 | MYLAB 70 ULTRASOUND IMAGING SYSTEM | Jun 01, 2005 | Substantially Equivalent | ESAOTE, S.P.A. |
| K051139 | ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM | May 13, 2005 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K051085 | DOPPLER-BOX | May 05, 2005 | Substantially Equivalent | COMPUMEDICS GERMANY GMGH |
| K050510 | ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 | Apr 01, 2005 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K050326 | 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 | Feb 28, 2005 | Substantially Equivalent | ESAOTE, S.P.A. |
| K050380 | XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A | Feb 23, 2005 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K050363 | FUKUDA DENSHI MODEL UF-850XTD | Feb 17, 2005 | Substantially Equivalent | FUKUDA DENSHI USA, INC. |
| K050240 | MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM | Feb 15, 2005 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA INC. |
| K043139 | USCOM 1A | Feb 15, 2005 | Substantially Equivalent | USCOM, LTD. |
| K050126 | GE LOGIQ TWIN | Feb 02, 2005 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K050099 | SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM | Jan 28, 2005 | Substantially Equivalent | KONTRON MEDICAL SYSTEMS SAS |
| K043588 | MYLAB 15 / MYLAB 20, MODEL 2700 | Jan 25, 2005 | Substantially Equivalent | PIE MEDICAL |
| K043554 | ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 | Jan 14, 2005 | Substantially Equivalent | B-K MEDICAL A/S |
| K050034 | SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM | Jan 13, 2005 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K043524 | ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 | Jan 13, 2005 | Substantially Equivalent | B-K MEDICAL A/S |
| K043559 | SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) | Jan 12, 2005 | Substantially Equivalent | SONOSITE,INC. |
| K043535 | HD11 DIAGNOSTIC ULTRASOUND SYSTEM | Jan 06, 2005 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K043455 | SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM | Dec 21, 2004 | Substantially Equivalent | MEDISON CO., LTD. |
| K043452 | TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM | Dec 21, 2004 | Substantially Equivalent | SONOSITE,INC. |
| K043196 | ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM | Nov 30, 2004 | Substantially Equivalent | ALOKA CO., LTD. |
| K043016 | SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM | Nov 16, 2004 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K042770 | MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM | Oct 20, 2004 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K042369 | SONOSCAPE ULTRASOUND SYSTEM SSI-1000/SSI-5000 | Oct 20, 2004 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K042326 | ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER | Sep 16, 2004 | Substantially Equivalent | UltraSonix Medical Corporation |
| K042055 | CYPRESS ULTRASOUND SYSTEM | Aug 16, 2004 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K042044 | ACUSON CV70 CARDIOVASCULAR SYSTEM | Aug 13, 2004 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K041915 | HEMO-DOP | Aug 04, 2004 | Substantially Equivalent | DWL ELEKTRONISCHE SYSTEME GMBH |
| K041916 | ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM | Jul 30, 2004 | Substantially Equivalent | ALOKA CO. LTD USA |
| K041813 | GE LOGIQ 7 ULTRASOUND BT04 | Jul 23, 2004 | Substantially Equivalent | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
| K041675 | PICUS, PARUS, FALCO AND AQUILA ULTRASOUND SYSTEMS | Jul 23, 2004 | Substantially Equivalent | PIE MEDICAL |
| K041688 | GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 | Jul 08, 2004 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K041552 | GE VIVID 7 BT04 | Jul 02, 2004 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K041499 | SSA-770A, APLIO VERSION 5.5 | Jun 10, 2004 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K040926 | ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000 | Jun 10, 2004 | Substantially Equivalent | HUDSON DIAGNOSTIC IMAGING LLC |
| K041319 | SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM | Jun 07, 2004 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K040596 | ULTRASOUND IMAGING SYSTEM, MODEL 7300 | Mar 31, 2004 | Substantially Equivalent | ESAOTE S.P.A. |
| K040409 | LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM | Feb 27, 2004 | Substantially Equivalent | LARSEN & TOUBRO LIMITED |
| K040251 | GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587 | Feb 20, 2004 | Substantially Equivalent | GE MED. SYSTEMS ULTRASOUND & PRIM. CARE DIAG.,LLC |
| K040060 | SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS | Jan 28, 2004 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K034003 | HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM | Jan 08, 2004 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K033367 | TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS ULTRASOUND SYSTEM, MODEL L03073, L02245, L02464 | Nov 05, 2003 | Substantially Equivalent | SONOSITE,INC. |
| K033209 | FUKUDA DENSHI MODEL FF SONIC UF-750XT | Oct 31, 2003 | Substantially Equivalent | FUKUDA DENSHI USA, INC. |
| K032656 | GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X | Oct 30, 2003 | Substantially Equivalent | GE MED. SYSTEMS ULTRASOUND & PRIM. CARE DIAG.,LLC |
| K033311 | ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM | Oct 29, 2003 | Substantially Equivalent | ALOKA CO., LTD. |
| K033139 | GE MARLIN ULTRASOUND | Oct 23, 2003 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K032477 | GE LOGIQ BOOK | Oct 22, 2003 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K032974 | GE LOGIQ 5 PRO OR EXPERT | Oct 21, 2003 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K031066 | VIEWMATE ULTRASOUND IMAGING SYSTEM | Oct 17, 2003 | Substantially Equivalent | EP MEDSYSTEMS |
| K033196 | SONOLINE ANTARES WITH CLARIFY VE | Oct 16, 2003 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K032620 | GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM | Oct 10, 2003 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K032503 | EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER | Aug 22, 2003 | Substantially Equivalent | HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K032329 | SA 9900 PLUS DIAGNOSTIC ULTRASOUND SYSTEM | Aug 06, 2003 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K032281 | SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM | Aug 06, 2003 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K032182 | GE LOGIQ 7, MODEL 2354858 | Jul 25, 2003 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K032114 | SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM | Jul 21, 2003 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K032111 | ACUSON CV70 CARDIOVASCULAR SYSTEM | Jul 18, 2003 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K031663 | GE VIVID 7, MODEL FC0003XX | Jun 09, 2003 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K031552 | MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS | May 30, 2003 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K020754 | NICOLET PIONEER TC8080 | Apr 21, 2003 | Substantially Equivalent | NICOLET BIOMEDICAL |
| K030934 | GE LOGIQ 9 MODEL 2375600 | Apr 17, 2003 | Substantially Equivalent | GE MEDICAL SYSTEMS, INC. |
| K030949 | TITAN HIGH RESOLUTION ULTRASOUND SYSTEM | Apr 07, 2003 | Substantially Equivalent | SONOSITE,INC. |
| K030455 | BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM | Mar 13, 2003 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K023255 | TECHNOS MP, MODEL AU6 | Feb 11, 2003 | Substantially Equivalent | BIOSOUND ESAOTE, INC. |
| K030191 | TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM | Jan 29, 2003 | Substantially Equivalent | TERATECH CORP. |
| K023512 | PICUS ULTRASOUND IMAGING SYSTEMS | Jan 24, 2003 | Substantially Equivalent | PIE MEDICAL |
| K024236 | ULTRASOUND SCANNER, TYPE 2400 | Jan 17, 2003 | Substantially Equivalent | B-K MEDICAL A/S |
| K022517 | USI-2000 ULTRASOUND SYSTEM WITH AUTOMATED SCANNING ACCESSORY | Dec 24, 2002 | Substantially Equivalent | U-SYSTEMS, INC. |
| K023996 | ALOKA SSD-3500 ULTRASOUND SYSTEM | Dec 18, 2002 | Substantially Equivalent | ALOKA CO., LTD. |
| K023957 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C2 SERIES) | Dec 12, 2002 | Substantially Equivalent | SONOSITE,INC. |
| K023720 | SONOLINE ANTARES ULTRASOUND SYSTEM | Nov 20, 2002 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K022858 | SUPERNOVA DIAGNOSTIC ULTRASOUND SCANNING SYSTEM | Sep 06, 2002 | Substantially Equivalent | NOVASONICS, INC. |
| K022567 | SEQUOIA SIGNATURE II DIAGNOSTIC ULTRASOUND SYSTEM | Aug 13, 2002 | Substantially Equivalent | ACUSON CORP. |
| K022400 | SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM | Aug 06, 2002 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K022303 | PHILIPS M2424 DIAGNOSTIC ULTRASOUND SYSTEM &PHILIPS 21315 DIAGNOSTIC ULTRASOUND TRANSDUCER | Jul 30, 2002 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K021497 | CYPRESS ULTRASOUND SYSTEM | Jul 09, 2002 | Substantially Equivalent | ACUSON CORP. |
| K021984 | PUNCTSURE ULTRASOUND VASCULAR IMAGING SYSTEM; PUNCTURESURE VASCULAR IMAGING PROCEDURE KIT | Jul 02, 2002 | Substantially Equivalent | INCEPTIO MEDICAL TECHNOLOGIES, LC |
| K020630 | ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER | Jun 13, 2002 | Substantially Equivalent | UltraSonix Medical Corporation |
| K013902 | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM USI-2000 | Jun 05, 2002 | Substantially Equivalent | U-SYSTEMS, INC. |
| K021628 | SONOSITE HAND-CARIED UNTRASOUND SYSTEM (POWERSERIES) | May 31, 2002 | Substantially Equivalent | SONOSITE,INC. |
| K014168 | AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION) | Apr 25, 2002 | Substantially Equivalent | BIOSOUND ESAOTE, INC. |
| K013848 | U-SYSTEMS DIAGNOSTIC ULTRASOUND SYSTEM U-2000 | Apr 08, 2002 | Substantially Equivalent | U-SYSTEMS, INC. |
| K020789 | GE VIVID 3 EXPERT; GE VIVID 3 PRO | Apr 04, 2002 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K020353 | OMNIA X/XS ULTRASOUND SYSTEM | Feb 13, 2002 | Substantially Equivalent | SIEMENS MEDICAL SYSTEMS, INC. |
| K013722 | MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER | Feb 11, 2002 | Substantially Equivalent | HITACHI MEDICAL CORP. |
| K020263 | LOGIQ 3 | Feb 06, 2002 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K014097 | GE LOGIQ 5 | Jan 10, 2002 | Substantially Equivalent | GE MEDICAL SYSTEMS |
| K014191 | M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540 | Jan 07, 2002 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS |
| K014116 | HAND-CARRIED ULTRASOUND SYSTEM | Dec 20, 2001 | Substantially Equivalent | SONOSITE,INC. |
| K013627 | SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM | Nov 16, 2001 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K012867 | SONOACE 9900 DIAGNOSTIC ULTRASOUND SYSTEM | Sep 12, 2001 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K012080 | SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM | Aug 29, 2001 | Substantially Equivalent | ALOKA CO., LTD. |
| K012369 | BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3 | Aug 10, 2001 | Substantially Equivalent | ATYS MEDICAL |
| K012239 | MODIFICATIONS TO EUB-525 DIAGNOSTIC ULTRASOUND SCANNER; EUB-2000 DIAGNOSTIC ULTRASOUND SCANNER; SP-711 SONOPROBE SYSTEM | Aug 10, 2001 | Substantially Equivalent | HITACHI MEDICAL CORP. |
| K012191 | TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC IMAGING MODES | Jul 26, 2001 | Substantially Equivalent | TERATECH CORP. |
| K011457 | ALOKA SSD-5500 WITH KI AND A-SMA | May 23, 2001 | Substantially Equivalent | ALOKA CO., LTD. |
| K011188 | GE LOGIQ 9, MODEL 2188900-X | May 18, 2001 | Substantially Equivalent | GE MEDICAL SYSTEMS |
| K011315 | SSD 5500 WITH OLYMPUS GF TYPE UC140P-AL5 | May 15, 2001 | Substantially Equivalent | ALOKA CO., LTD. |
| K011224 | HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY | May 04, 2001 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K003986 | ULTRASOUND SCANNER TYPE 2102 | Apr 03, 2001 | Substantially Equivalent | B-K MEDICAL A/S |
| K010649 | EXHALE DOPPLER SYSTEM | Mar 20, 2001 | Substantially Equivalent | BRONCUS TECHNOLOGIES, INC. |
| K010631 | NEMIO | Mar 15, 2001 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K010405 | 7230 ULTRASOUND IMAGING SYSTEM WITH TEI | Mar 13, 2001 | Substantially Equivalent | BIOSOUND ESAOTE, INC. |
| K010329 | LOGIQ 500 | Mar 01, 2001 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K010374 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM | Feb 21, 2001 | Substantially Equivalent | SONOSITE,INC. |
| K003515 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200 | Feb 12, 2001 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K003514 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200 | Feb 12, 2001 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K003931 | VIVID 7 WITH SONOPAC, MODEL FB0008XX | Jan 18, 2001 | Substantially Equivalent | GE MEDICAL SYSTEMS, INC. |
| K003479 | U-SYSTEMS ULTRASOUND SYSTEM USI-2000 | Jan 18, 2001 | Substantially Equivalent | U-SYSTEMS, INC. |
| K003739 | ALOKA SSD-4000 | Dec 27, 2000 | Substantially Equivalent | ALOKA CO., LTD. |
| K003525 | VOLUSON 730 DIAGNOSTIC ULTRASOUND SYSTEM | Nov 22, 2000 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K003399 | SONOSITE HAND-CARRIED ULTRASOUND SYSTEM | Nov 16, 2000 | Substantially Equivalent | SONOSITE,INC. |
| K002880 | 300LC ULTRASOUND IMAGING SYSTEMS, MODEL 300LC | Oct 26, 2000 | Substantially Equivalent | PIE MEDICAL |
| K003125 | SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM | Oct 20, 2000 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K002470 | M2424A SONOS 5500/4500 DIAGNOSTIC ULTRASOUND SYSTEM, VERSION B.2. 21330A TRANSDUCER | Sep 08, 2000 | Substantially Equivalent | AGILENT TECHNOLOGIES, INC. |
| K002533 | TCD 100M, PWD13 TRANSDUCER | Aug 30, 2000 | Substantially Equivalent | SPENCER TECHNOLOGIES |
| K002491 | COMBISON 301 PW ULTRASOUND SYSTEM AND TRANSDUCERS | Aug 25, 2000 | Substantially Equivalent | MEDISON CO., LTD. |
| K002397 | M2430 DIAGNOSTIC ULTRASOUND SYSTEM WITH THE 21420 TRANSDUCER | Aug 17, 2000 | Substantially Equivalent | AGILENT TECHNOLOGIES, INC. |
| K002239 | SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM | Aug 08, 2000 | Substantially Equivalent | KONTRON MEDICAL SYSTEMS SAS |
| K990517 | EXPLORER CVS TRANSCRANIAL DOPPLER | Aug 01, 2000 | Substantially Equivalent | DIAGNOSTIC MEDICAL SYSTEMS |
| K002185 | SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM | Aug 01, 2000 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K001400 | ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM | Aug 01, 2000 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K002003 | HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING | Jul 13, 2000 | Substantially Equivalent | ATL ULTRASOUND, INC. |
| K993939 | NICOLET EME LEGEND TC22 | Jun 29, 2000 | Substantially Equivalent | NICOLET BIOMEDICAL |
| K001711 | M2410B IMAGEPOINT HX MULTISPECIALTY SYSTEM, VERSION B.1 | Jun 20, 2000 | Substantially Equivalent | AGILENT TECHNOLOGIES, INC. |
| K000931 | AU5 ULTRASOUND IMAGING SYSTEM | Jun 08, 2000 | Substantially Equivalent | BIOSOUND ESAOTE, INC. |
| K001267 | GE SYSTEM FIVE | May 12, 2000 | Substantially Equivalent | GE MEDICAL SYSTEMS, INC. |
| K000415 | OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM | Apr 11, 2000 | Substantially Equivalent | OPTIMAL IMAGING SYSTEMS, INC. |
| K994026 | EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER | Mar 29, 2000 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K994369 | 7250 (MEGAS) | Feb 24, 2000 | Substantially Equivalent | BIOSOUND ESAOTE, INC. |
| K000034 | OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM | Feb 24, 2000 | Substantially Equivalent | OPTIMAL IMAGING SYSTEMS, INC. |
| K994096 | SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM | Dec 20, 1999 | Substantially Equivalent | SONOSITE,INC. |
| K984203 | SIUI APOGEE 800PLUS ULTRASOUND IMAGING SYSTEM | Nov 01, 1999 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
| K992663 | ALOKA SSD-5500 DIAGNOSTIC ULTRASOUND SYSTEM | Aug 24, 1999 | Substantially Equivalent | ALOKA CO., LTD. |
| K991805 | ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION | Aug 02, 1999 | Substantially Equivalent | ACUSON CORP. |
| K991872 | LYNX ULTRASOUND SYSTEM | Jun 16, 1999 | Substantially Equivalent | ECTON, INC. |
| K991858 | SSA-390A/POWER VISION 8000 | Jun 16, 1999 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K990360 | AU6 | Apr 30, 1999 | Substantially Equivalent | BIOSOUND ESAOTE, INC. |
| K990970 | SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED ULTRASOUND SYSTEM AND TRANSDUCERS | Apr 07, 1999 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K990806 | C1 ULTRASOUND SYSTEM | Mar 26, 1999 | Substantially Equivalent | SONOSITE,INC. |
| K990339 | SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O | Feb 18, 1999 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K984307 | MODIFICATION OF: RHEO DOPPLEX II | Jan 12, 1999 | Substantially Equivalent | HUNTLEIGH HEALTHCARE, INC. |
| K981834 | PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM | Sep 29, 1998 | Substantially Equivalent | PERCEPTION, INC. |
| K974813 | COMBISON 530D WITH POWER DOPPLER MODE | Sep 29, 1998 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K980468 | AU5 ULTRASOUND IMAGING SYSTEM | Aug 26, 1998 | Substantially Equivalent | BIOSOUND ESAOTE, INC. |
| K974269 | SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, | Aug 21, 1998 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K982498 | DIAGNOSTIC ULTRASOUND SYSTEM | Aug 07, 1998 | Substantially Equivalent | VOLUMETRICS MEDICAL IMAGING, INC. |
| K974588 | INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD | Aug 07, 1998 | Substantially Equivalent | RIMED LTD. |
| K981397 | HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC ULTRASOUND SYSTEM SSA-380A, POWERVISION 7000 | Jul 31, 1998 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K980557 | SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING | Apr 24, 1998 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K973556 | IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000 | Apr 24, 1998 | Substantially Equivalent | IMEX MEDICAL SYSTEMS, INC. |
| K973562 | IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100 | Apr 15, 1998 | Substantially Equivalent | IMEX MEDICAL SYSTEMS, INC. |
| K971790 | KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM) | Dec 17, 1997 | Substantially Equivalent | UROMETRICS, INC. |
| K960527 | LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM | Sep 08, 1997 | Substantially Equivalent | GE MEDICAL SYSTEMS |
| K972465 | ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM | Aug 15, 1997 | Substantially Equivalent | ALOKA CO., LTD. |
| K964886 | GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM | Jul 29, 1997 | Substantially Equivalent | GE MEDICAL SYSTEMS |
| K954220 | EUB-8000 | May 07, 1997 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K964309 | SONOS 2000, SONOS 2500 (M2406 A) | Apr 22, 1997 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K963616 | ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM | Apr 03, 1997 | Substantially Equivalent | ALOKA CO., LTD. |
| K964699 | RHEO DOPPLEX II (RD 2) | Feb 21, 1997 | Substantially Equivalent | HUNTLEIGH TECHNOLOGY, INC. |
| K962796 | NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM | Jan 21, 1997 | Substantially Equivalent | MEDASONICS, INC. |
| K963705 | COLOR ENHANCEMENT FUNCTION FOR THE SSA-380A | Dec 02, 1996 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K954028 | HP SONOS ULTRASOUND IMAGING SYSTEM | Aug 08, 1996 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K935024 | ESI-5000 | Jun 12, 1996 | Substantially Equivalent | ELSCINT, INC. |
| K945957 | AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER | Apr 15, 1996 | Substantially Equivalent | KLEINFELD, KAPLAN AND BECKER |
| K955327 | HP SONOS 100CF ULTRASOUND IMAGING SYSTEM | Apr 08, 1996 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K951998 | DIASONICS MASTERS SERIES 5000 ULTRASOUND SCANNER | Mar 27, 1996 | Substantially Equivalent | DIASONICS ULTRASOUND |
| K960602 | SSA-340A (MODIFICATION) | Mar 21, 1996 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K946277 | TETRAD 2300 E/U ULTRASOUNG IMAGING SYSTEM | Mar 15, 1996 | Substantially Equivalent | TETRA CORP. |
| K954022 | ALOKA OMNIVIEW DIAGNOSTIC ULTRASOUND SYSTEM | Jan 17, 1996 | Substantially Equivalent | ALOKA CO., LTD. |
| K941352 | SSA-340A | Dec 22, 1995 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K945072 | SIEMENS Q4000 | Nov 21, 1995 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K936067 | ATLAS 1.0 DIAGNOSTIC ULTRASOUND SYSTEM | Oct 27, 1995 | Substantially Equivalent | ATLANTIS DIAGNOSTICS INTL., INC. |
| K945773 | SIEMENS SONOLINE VERSA | Aug 07, 1995 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K951695 | OPERAND* ULTRASOUND TRANSMISSION GEL | May 12, 1995 | Substantially Equivalent | REDI PRODUCTS, INC. |
| K944048 | ULTRASOUND 77030 IMAGING SYSTEM | Mar 01, 1995 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K930458 | MULTI-DOP L | Feb 03, 1995 | Substantially Equivalent | DANTEC MEDICAL, INC. |
| K943863 | NEEDLE GUIDE | Dec 29, 1994 | Substantially Equivalent | BIOPSYS MEDICAL, INC. |
| K935923 | PHILIPS ULTRASOUND P800 IMAGING SYSTEM | Dec 08, 1994 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K941652 | ALOKA SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM MODIFICATION | Oct 21, 1994 | Substantially Equivalent | ALOKA CO., LTD. |
| K934915 | ACUSON MODEL 2001 | Oct 21, 1994 | Substantially Equivalent | ACUSON CORP. |
| K933743 | SSA-380A | Oct 20, 1994 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K935009 | PEGASUS | Oct 11, 1994 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K933916 | AUSONICS OPUS 2 REALTIME ULTRASOUND SCANNER | Oct 03, 1994 | Substantially Equivalent | AUSONICS PTY LTD. |
| K934041 | HEWLETT PACKARD CONOS ULTRASOUND IMAGING SYSTEM MODIFICATION | Sep 22, 1994 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K933202 | VENUS DIAGNOSTIC ULTRASOUND SYSTEM | Jun 27, 1994 | Substantially Equivalent | GE MEDICAL SYSTEMS |
| K915403 | DIAGNOSTIC ULTRASOUND SYSTEM | May 03, 1994 | Substantially Equivalent | HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K940285 | ACUSON PICTURE ARCHIVING & COMMUNICATION SYSTEM MODIFICATION | Apr 29, 1994 | Substantially Equivalent | ACUSON CORP. |
| K931293 | SSH-140A FETAL DOPPLER SYSTEM | Feb 09, 1994 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K926351 | COLORMARK(TM) VISUALIZATION SYSTEM | Sep 16, 1993 | Substantially Equivalent | ECHOCATH, INC. |
| K924204 | NEW ULTRASOUND IMAGING SYSTEM & TRANSDUCERS | Jun 07, 1993 | Substantially Equivalent | TETRA CORP. |
| K914862 | CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS | Dec 03, 1992 | Substantially Equivalent | MEDASONICS, INC. |
| K912819 | SC1150 CW/PD | Jan 09, 1992 | Substantially Equivalent | PIE MEDICAL EQUIPMENT B.V. |
| K905198 | DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535 | Aug 28, 1991 | Substantially Equivalent | BRUEL & KJAER |
| K904017 | SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES | Mar 21, 1991 | Substantially Equivalent | SIEMENS ULTRASOUND, INC. |
| K904359 | ESI-3000 ULTRASOUND SYSTEM | Mar 05, 1991 | Substantially Equivalent | ELSCINT, INC. |
| K902691 | DOPPLER OPTION FOR PLATINUM | Jan 02, 1991 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS, INC. |
| K901329 | CEPHALIC DOPPLER W/ULTRAMARK 9 ULTRASOUND SYSTEM | Nov 23, 1990 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K893861 | TMI LW-100 PULSED DOPPLER SYSTEM | Feb 05, 1990 | Substantially Equivalent | TITRONICS MEDICAL INSTRUMENTS, INC. |
| K894163 | PHASE 2 TRANSCRANIAL PROBE | Sep 12, 1989 | Substantially Equivalent | BIOSOUND, INC. |
| K894054 | 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER | Sep 12, 1989 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K893833 | AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM W/DOPPLER | Sep 11, 1989 | Substantially Equivalent | ACOUSTIC IMAGING |
| K893042 | CATHSCANNER(R) INTRAVASCULAR ULTRA IMAGING SYSTEM | Jul 19, 1989 | Substantially Equivalent | ENDOSONICS CORP. |
| K885211 | RF-100 MONITOR, RF-P-2.5, RF-P-5, RF-P-7.5 PROBES | Jun 13, 1989 | Substantially Equivalent | RF DESIGN ASSOC., INC. |
| K891238 | SIEMENS TRANSESOPHAGEAL ECHO TEE TRANSDUCER | Jun 05, 1989 | Substantially Equivalent | SIEMENS ULTRASOUND, INC. |
| K890055 | ACUSON S228 TRANSDUCER FOR TRANSCRANIAL DOPPLER | May 16, 1989 | Substantially Equivalent | ACUSON CORP. |
| K890998 | QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL. | May 02, 1989 | Substantially Equivalent | QUANTUM MEDICAL SYSTEMS, INC. |
| K885155 | MENTOR MDS | Mar 14, 1989 | Substantially Equivalent | IMEX |
| K882585 | CAVROLAB | Mar 02, 1989 | Substantially Equivalent | LIFE-TECH INTL., INC. |
| K882755 | MODEL 500V VASCULAR SPECTRUM ANALYZER | Nov 29, 1988 | Substantially Equivalent | MULTIGON INDUSTRIES, INC. |
| K882737 | ACUSON I7505 TRANSDUCER, ULTRASOUND TRANSDUCER | Sep 08, 1988 | Substantially Equivalent | ACUSON CORP. |
| K882015 | TRANSCRAN(TM) TRANSCRANIAL PULSED DOPPLER SYSTEM | Sep 08, 1988 | Substantially Equivalent | ULTRAMED, INC. |
| K872817 | 5 MHZ DOPPLER OUTRIGGER | Feb 08, 1988 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K872292 | TRANSPECT TRANSCRANIAL DOPPLER | Aug 14, 1987 | Substantially Equivalent | MEDASONICS, INC. |
| K863577 | DOPPLER UNIT, SDS-100A | Feb 25, 1987 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K850071 | TECA MF-20 MICROVASCULAR DOPPLER | Apr 02, 1985 | Substantially Equivalent | TECA, INC. |
| K844293 | AUTO DII MULTI FREQUENCY | Feb 13, 1985 | Substantially Equivalent | TECHNICARE CORP. |
| K842407 | PULSED DOPPLER OPTION, CONTINU-WAVE | Feb 13, 1985 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K842055 | PICKER ARTIS ULTRASOUND IMAGING SYS | Aug 24, 1984 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K840140 | DOPPLER IMAGING OPTION | Aug 23, 1984 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K840953 | ACCESS SCANHEADSS | Jun 15, 1984 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K840402 | AUDIO BANDWIDTH ANALYZER | May 09, 1984 | Substantially Equivalent | D. E. HOKANSON, INC. |
| K813544 | IREX 2D/DOPPLER PHASE ARRAY IMAGING SYS. | Feb 05, 1982 | Substantially Equivalent | IREX CORP. |
| K812606 | SECTORTAC | Oct 13, 1981 | Substantially Equivalent | ECHO LABORATORIES, INC. |
| K810133 | ULTRAPROBE | Jun 09, 1981 | Substantially Equivalent | ARS MAGNA |
| K810118 | LS1000 ELECTRONIC FOCUS | Feb 19, 1981 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K803246 | ULTRASONIC STETHOSCOPE | Jan 28, 1981 | Substantially Equivalent | SONICAID, INC. |
| K802979 | DIASONICS SMALL PARTS SCANNER | Jan 22, 1981 | Substantially Equivalent | DIASONICS, INC. |
| K802254 | GENERAL ULTRASOUND EXAM. TABLE | Nov 26, 1980 | Substantially Equivalent | ENGINEERING DYNAMICS CORP. |
| K801972 | TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX | Oct 23, 1980 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K801656 | EDP 1200 SECTOR SCANNER OPTION | Sep 26, 1980 | Substantially Equivalent | UNIRAD CORP. |
| K801655 | AUTO SECTOR SCANNER | Sep 26, 1980 | Substantially Equivalent | UNIRAD CORP. |
| K801512 | DOPPLER ULTRASONIC STETHOSCOPE | Aug 20, 1980 | Substantially Equivalent | MOUNTAIN MEDICAL EQUIPMENT, INC. |
| K781642 | RA-I | Oct 10, 1978 | Substantially Equivalent | DIASONICS, INC. |
FEI Numbers
This FDA classification entry is associated with 211 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 211 registration numbers. Click on an entry to view related FDA registrations.