System, Imaging, Pulsed Echo, Ultrasonic
A pulsed echo ultrasonic imaging system uses reflected sound waves to produce real-time cross-sectional images of internal organs and tissues, widely applied in diagnostic imaging across multiple clinical specialties. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) clearance before commercial distribution. The product code is IYO, regulated under 21 CFR 892.1560, within the Radiology medical specialty. This device is eligible for third-party review.
Basic Information
- Product Code
- IYO
- Device Class
- FDA class 2
- Regulation Number
- 892.1560
- 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 884 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243227 | B-Scan | Jul 11, 2025 | Substantially Equivalent | ACCUTOME, INC. Doing Business As Keeler USA |
| K251728 | Velacur One (LI-1100) | Jun 26, 2025 | Substantially Equivalent | Sonic Incytes Medical Corp |
| K243937 | Accuro 3S | May 23, 2025 | Substantially Equivalent | Rivanna Medical, Inc. |
| K243479 | EchoGuide (Version 1) | Apr 23, 2025 | Substantially Equivalent | Sonavex, Inc. |
| K242496 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) | Nov 19, 2024 | Substantially Equivalent | Eieling Technology (Shenzhen) Limited |
| K241029 | SpineUs System | Oct 07, 2024 | Substantially Equivalent | Verdure Imaging |
| K233977 | Velacur | Sep 04, 2024 | Substantially Equivalent | Sonic Incytes |
| K233579 | SC1 Handheld Ultrasound Imaging system (Model: SC1) | Jun 26, 2024 | Substantially Equivalent | FCU Co., Ltd. |
| K233613 | ACUSON SC2000 Diagnostic Ultrasound System | Jun 12, 2024 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K232895 | B-Ultrasound Diagnostic System | May 03, 2024 | Substantially Equivalent | Contec Medical Systems Co., Ltd. |
| K232302 | Pocket III | Apr 26, 2024 | Substantially Equivalent | Quantel Medical |
| K231677 | EdgeFlow UH10 | Mar 06, 2024 | Substantially Equivalent | Edgecare Inc. |
| K240146 | BD Prevue II Peripheral Vascular Access System | Feb 18, 2024 | Substantially Equivalent | Bard Access Systems, Inc. |
| K233401 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) | Feb 12, 2024 | Substantially Equivalent | Eieling Technology Limited |
| K230986 | Bladder Scanner | Dec 29, 2023 | Substantially Equivalent | Avantsonic Technology Co., Ltd. |
| K232320 | iSR`obot Mona Lisa 2.0 | Dec 21, 2023 | Substantially Equivalent | Biobot Surgical Pte Ltd |
| K231889 | Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) | Dec 21, 2023 | Substantially Equivalent | Ultrasound Biotechnology (Shanghai) Co., Ltd. |
| K230511 | K3900 Ultrasound Imaging System | Oct 25, 2023 | Substantially Equivalent | MAUI Imaging |
| K232459 | Velacur | Sep 12, 2023 | Substantially Equivalent | Sonic Incytes |
| K231283 | SiteRite 9 Ultrasound System | Sep 11, 2023 | Substantially Equivalent | Bard Access Systems, Inc. (C.R. Bard, Inc.) |
| K223448 | Bladder Scanner Model: BVT02 | Jul 07, 2023 | Substantially Equivalent | Xuzhou Kaixin Electronic Instrument Co., Ltd. |
| K223287 | Velacur | Apr 20, 2023 | Substantially Equivalent | Sonic Incytes |
| K220068 | Butterfly iQ/iQ+ Ultrasound System | Mar 31, 2023 | Substantially Equivalent | Butterfly Network, Inc. |
| K223902 | FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) | Mar 02, 2023 | Substantially Equivalent | Echosens |
| K222787 | Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P | Jan 09, 2023 | Substantially Equivalent | Chongqing Sunkingdom Medical Instrument Co., Ltd |
| K220933 | QT Scanner 2000 Model A | Aug 31, 2022 | Substantially Equivalent | QT Imaging, Inc. |
| K213488 | Bladder Scanner, Model Name:M5 | Jul 01, 2022 | Substantially Equivalent | Suzhou Peaksonic Medical Technology Co., Ltd. |
| K211529 | NAVIRFA Scope | May 05, 2022 | Substantially Equivalent | NaviFUS Corporation |
| K213620 | ATUSA Automated 3D Breast Ultrasound System | Apr 22, 2022 | Substantially Equivalent | iSono Health, Inc. |
| K212851 | EchoSK and EchoSGyn modules for EchoS Family devices | Mar 16, 2022 | Substantially Equivalent | Echolight S.p.A |
| K213411 | iSRobot Mona Lisa 2.0 | Dec 22, 2021 | Substantially Equivalent | Biobot Surgical Pte Ltd |
| K213303 | Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 | Dec 07, 2021 | Substantially Equivalent | Infraredx, Inc. |
| K213070 | MD-320W Ultrasound Biomicroscope | Nov 18, 2021 | Substantially Equivalent | Meda Co., LTD |
| K213254 | Axialis Ophthalmic Ultrasound System | Nov 15, 2021 | Substantially Equivalent | Quantel Medical |
| K211726 | Acuson SC2000 Diagnostic Ultrasound System | Nov 05, 2021 | Substantially Equivalent | Siemens Medical Solutions USA, Inc. |
| K212035 | FibroScan 230 | Jul 30, 2021 | Substantially Equivalent | Echosens |
| K210468 | SC1 Handheld Ultrasound Imaging System (Model: SC1) | Jul 23, 2021 | Substantially Equivalent | FCU Co., Ltd. |
| K203659 | iSR'obot Mona Lisa 1.0 | Jul 08, 2021 | Substantially Equivalent | Biobot Surgical Pte Ltd |
| K211193 | BD Prevue II Peripheral Vascular Vascular Access System | Jun 25, 2021 | Substantially Equivalent | Bard Access Systems, Inc, (C.R. Bard, Inc.) |
| K211623 | THD Procto Software System | Jun 24, 2021 | Substantially Equivalent | THD SpA |
| K210591 | Palm Bladder Scanner - PBSV7.1 | Jun 09, 2021 | Substantially Equivalent | Mianyang Meike Electronic Equipment Co., Ltd. |
| K211098 | Breast Volume Navigator (BVN) Model G-2000 | May 26, 2021 | Substantially Equivalent | MetriTrack, Inc. |
| K203273 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) | Mar 25, 2021 | Substantially Equivalent | Echosens |
| K201316 | Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) | Feb 26, 2021 | Substantially Equivalent | Suzhou Peaksonic Medical Technology Co., Ltd |
| K203719 | IntraSight Mobile | Jan 19, 2021 | Substantially Equivalent | Volcano Corporation |
| K202119 | AcuSee AS-P1000 System | Oct 07, 2020 | Substantially Equivalent | Weipeng (Suzhou) Medical Devices Co., Ltd. |
| K201995 | CUBEScan BioCon-1100 | Aug 19, 2020 | Substantially Equivalent | Mcube Technology Co., Ltd. |
| K201597 | Liver Incytes, Model 1005 | Jul 31, 2020 | Substantially Equivalent | Sonic Incytes |
| K200655 | FibroScan® 630 | Jul 16, 2020 | Substantially Equivalent | Echosens |
| K200980 | Auto 3D Bladder Volume Tool | Jun 11, 2020 | Substantially Equivalent | Butterfly Network, Inc. |
| K200749 | CUBEScan BioCon-900S | May 19, 2020 | Substantially Equivalent | Mcube Technology Co., Ltd. |
| K200548 | CUBEScan BioCon-1100 | Mar 27, 2020 | Substantially Equivalent | Mcube Technology Co., Ltd. |
| K200136 | Shear Wave Quantificational Ultrasound Diagnostic System | Mar 17, 2020 | Substantially Equivalent | Wuxi Hisky Medical Technologies Co., Ltd. |
| K192253 | SonicEye Dual-Array Ultrasound System | Feb 25, 2020 | Substantially Equivalent | Sonivate Medical Inc |
| K193512 | THD Procto Software System | Jan 26, 2020 | Substantially Equivalent | THD SpA |
| K192170 | VistaScan USB Ultrasound Imaging System | Jan 23, 2020 | Substantially Equivalent | Emagine Solutions Technology, LLC |
| K192791 | Diagnostic Ultrasound System | Nov 27, 2019 | Substantially Equivalent | Edan Instruments, Inc. |
| K192573 | Dolphin Medical Imaging USB Ultrasound System | Nov 19, 2019 | Substantially Equivalent | Dolphin Medical Imaging, LLC |
| K190646 | QT Scanner 2000 Model A | Oct 18, 2019 | Substantially Equivalent | QT Ultrasound, LLC |
| K190314 | Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 | Oct 09, 2019 | Substantially Equivalent | MedNovel Technology Ltd |
| K191541 | Vave Personal Ultrasound System | Jul 10, 2019 | Substantially Equivalent | Vave Health, Inc. |
| K183173 | LIGHTMED Ultrasound System | Jul 01, 2019 | Substantially Equivalent | Lightmed USA, Inc |
| K191307 | Palm Bladder Scanner - PBSV5.1 | Jun 05, 2019 | Substantially Equivalent | Mianyang Meike Electronic Equipment Co., Ltd. |
| K190769 | Bladder Scanner (Models: M2, M2-W, M1, M1-W) | May 22, 2019 | Substantially Equivalent | Suzhou Lischka Medtech Co., Ltd. |
| K182460 | MD-6000P Bladder Scanner | May 06, 2019 | Substantially Equivalent | Meda Co., LTD |
| K190786 | Eye Prime | Apr 11, 2019 | Substantially Equivalent | Ellex Medical Pty Ltd. |
| K190186 | Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System | Mar 28, 2019 | Substantially Equivalent | Edan Instruments, Inc. |
| K183414 | ABSOLU | Mar 20, 2019 | Substantially Equivalent | Quantel Medical |
| K190039 | EchoSure Diagnostic Ultrasound System | Mar 08, 2019 | Substantially Equivalent | Sonavex, Inc |
| K182281 | Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech | Oct 24, 2018 | Substantially Equivalent | C.R. Bard |
| K182213 | QT Ultrasound Breast Scanner - 1 | Sep 14, 2018 | Substantially Equivalent | QT Ultrasound LLC |
| K182153 | Ultrasound System SONIMAGE HS1 | Sep 06, 2018 | Substantially Equivalent | KONICA MINOLTA, INC. |
| K181574 | Uscan | Jul 10, 2018 | Substantially Equivalent | EchoNous, Inc. |
| K181547 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Jul 09, 2018 | Substantially Equivalent | Echosens |
| K173595 | Shear Wave Quantificational Ultrasound Diagnostic System | Jun 22, 2018 | Substantially Equivalent | Wuxi Hisky Medical Technologies Co., Ltd. |
| K180636 | ExactVu High Resolution Micro-Ultrasound System | Apr 30, 2018 | Substantially Equivalent | Exact Imaging Inc. |
| K170761 | LIGHTSonic BUBM | Apr 13, 2018 | Substantially Equivalent | Lightmed USA, Inc. |
| K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System | Apr 11, 2018 | Substantially Equivalent | Volcano Corporation |
| K180265 | COMPACT TOUCH Ophthalmic Ultrasound System | Mar 02, 2018 | Substantially Equivalent | Quantel Medical |
| K172256 | SoftVue | Mar 02, 2018 | Substantially Equivalent | Delphinus Medical Technologies |
| K172750 | Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe) | Feb 28, 2018 | Substantially Equivalent | Guangzhou Sonostar Technologies Co., Ltd. |
| K180084 | Ultrasound System SONIMAGE MX1 | Feb 08, 2018 | Substantially Equivalent | Konica Minolta, Inc. |
| K171528 | Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) | Jan 24, 2018 | Substantially Equivalent | Avantsonic Technology Co., Ltd. |
| K172056 | InnoSight Diagnostic Ultrasound System | Dec 13, 2017 | Substantially Equivalent | Qisda Corporation |
| K170046 | Lilium a-200E | Dec 07, 2017 | Substantially Equivalent | Lilium Otsuka Co., Ltd. |
| K172931 | DUS-6000 Digital Ultrasonic Diagnostic Imaging System | Dec 01, 2017 | Substantially Equivalent | Advanced Instrumentations, Inc. |
| K170856 | CMS600P2 B-Ultrasound Diagnostic System | Nov 17, 2017 | Substantially Equivalent | Contec Medical Systems Co., LTD. |
| K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | Nov 14, 2017 | Substantially Equivalent | Echosens |
| K173138 | Biim Diagnostic Ultrasound System | Oct 27, 2017 | Substantially Equivalent | Biim Ultrasound AS |
| K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit | Oct 25, 2017 | Substantially Equivalent | Volcano Corporation |
| K171594 | Accuro | Oct 20, 2017 | Substantially Equivalent | Rivanna Medical, LLC |
| K171309 | BR-FHUS Navigation 1.0 | Sep 29, 2017 | Substantially Equivalent | TaiHao Medical Inc. |
| K172356 | BladderScan Prime PLUS System | Sep 15, 2017 | Substantially Equivalent | Verathon Incorporated |
| K172142 | FibroScan 430 Mini+ | Sep 13, 2017 | Substantially Equivalent | Echosens |
| K171301 | Scanmate Flex | Jul 31, 2017 | Substantially Equivalent | DGH Technology, Inc. |
| K171824 | Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System | Jul 18, 2017 | Substantially Equivalent | Edan Instruments Inc |
| K171766 | Acuson SC2000 Diagnostic Ultrasound System | Jul 12, 2017 | Substantially Equivalent | Siemens Medical Solutions Inc. |
| K171591 | CUBEScan BioCon-900 (Bladder Volume Measurement System) | Jun 22, 2017 | Substantially Equivalent | Mcube Technology Co., Ltd. |
| K161354 | MELODY, Remote Control System for Ultrasound Probe | Jun 12, 2017 | Substantially Equivalent | AdEcho Tech |
| K162372 | QT Ultrasound Breast Scanner-1 | Jun 06, 2017 | Substantially Equivalent | QT ULTRASOUND LLC |
| K170133 | FFR V2.5 | May 26, 2017 | Substantially Equivalent | Philips Volcano |
| K170385 | CORE M2 Vascular System | Apr 06, 2017 | Substantially Equivalent | Volcano Corporation |
| K162972 | ExactVu High Resolution Micro-Ultrasound System | Dec 02, 2016 | Substantially Equivalent | Exact Imaging |
| K161968 | MicrUs | Nov 03, 2016 | Substantially Equivalent | TELEMED |
| K161342 | Sonic Window | Jun 15, 2016 | Substantially Equivalent | ANALOGIC CORPORATION |
| K161300 | Acclarix AX8 Diagnostic Ultrasound System | May 31, 2016 | Substantially Equivalent | EDAN INSTRUMENTS INC. |
| K153620 | Enovare Ultrasound System | May 05, 2016 | Substantially Equivalent | OREON TECHNOLOGIES INC. |
| K160792 | Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound | Apr 15, 2016 | Substantially Equivalent | THE PROMETHEUS GROUP |
| K153581 | Bladder Scanner | Apr 08, 2016 | Substantially Equivalent | Caresono Technology Co., Ltd. |
| K160420 | SpeqT | Mar 21, 2016 | Substantially Equivalent | Signostics Limited |
| K160524 | FibroScan 530 Compact | Mar 18, 2016 | Substantially Equivalent | ECHOSENS |
| K153416 | ArcScan Insight 100 | Feb 02, 2016 | Substantially Equivalent | ARCSCAN, INC. |
| K153369 | SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz | Dec 22, 2015 | Substantially Equivalent | VOLCANO CORPORATION |
| K152554 | Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology | Dec 14, 2015 | Substantially Equivalent | C.R. Bard, Inc. |
| K152573 | 4Sight | Nov 25, 2015 | Substantially Equivalent | ACCUTOME, INC. |
| K153101 | BladderScan Prime System | Nov 19, 2015 | Substantially Equivalent | VERATHON INCORPORATED |
| K152318 | MD-2300S Ultrasonic A/B Scanner for Ophthalmology | Nov 17, 2015 | Substantially Equivalent | MEDA CO.,LTD |
| K152316 | iLab Ultrasound Imaging System | Sep 18, 2015 | Substantially Equivalent | BOSTON SCIENTIFIC |
| K151339 | SONON Ultrasound Imaging System (Model: SONON 300C) | Sep 10, 2015 | Substantially Equivalent | HEALCERION CO., LTD. |
| K150239 | FibroScan | Sep 01, 2015 | Substantially Equivalent | Echosens |
| K151709 | Hi-Light Diagnostic Ultrasound Systems | Jul 17, 2015 | Substantially Equivalent | Qingdao Hisense Medical Equipment Co., Ltd. |
| K151060 | Ultrasound System SONIMAGE HS1 | Jun 05, 2015 | Substantially Equivalent | KONICA MINOLTA, INC. |
| K150949 | FibroScan | Jun 03, 2015 | Substantially Equivalent | ECHOSENS |
| K150342 | Touch Ultrasound | May 08, 2015 | Substantially Equivalent | CARESTREAM HEALTH, INC. |
| K150999 | Acclarix Diagnostic Ultrasound System | May 06, 2015 | Substantially Equivalent | EDAN INSTRUMENTS, INC. |
| K150580 | UltraVision 2 Diagnostic Ultrasound System | Apr 07, 2015 | Substantially Equivalent | WINPROBE CORPORATION |
| K150529 | Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System | Mar 30, 2015 | Substantially Equivalent | C.R. Bard, Inc |
| K150441 | Volcano iFR Modality, iFR Scout feature | Mar 20, 2015 | Substantially Equivalent | VOLCANO CORPORATION |
| K143122 | Volcano iFR Harvest Software (Offline) | Feb 20, 2015 | Substantially Equivalent | Volcano Corporation |
| K143396 | omni TRAX Active Patient Tracker | Jan 23, 2015 | Substantially Equivalent | CIVCO Medical Instruments Co Inc dba CIVCO Medical Solutions |
| K143493 | SignosRT Bladder Ultrasound System | Jan 14, 2015 | Substantially Equivalent | Signostics Ltd |
| K142329 | BBS REVOLUTION | Dec 15, 2014 | Substantially Equivalent | dBMEDx INC. |
| K142517 | SoftVue | Oct 31, 2014 | Substantially Equivalent | DELPHINUS MEDICAL TECHNOLOGIES, INC |
| K142443 | Site-Rite 6 Ultrasound System with Pinpoint GT Technology | Oct 30, 2014 | Substantially Equivalent | C.R. Bard, Inc |
| K142054 | IMACOR ZURA EVO IMAGING SYSTEM | Sep 29, 2014 | Substantially Equivalent | IMACOR INC. |
| K141806 | CLEAR GUIDE ONE | Sep 19, 2014 | Substantially Equivalent | CLEAR GUIDE MEDICAL |
| K142395 | SC2000 and ACUSON X300 Diagnostic Ultrasound Systems | Sep 09, 2014 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K140428 | ULTRASOUND SCANNER SYSTEM BK2300 | May 30, 2014 | Substantially Equivalent | B-K MEDICAL APS |
| K140899 | HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM | May 05, 2014 | Substantially Equivalent | HALO MEDICAL TECHNOLOGIES, LLC |
| K140199 | VUPAD | Apr 01, 2014 | Substantially Equivalent | SONOMED, INC. |
| K133323 | VOLCANO IFR MODALITY | Mar 14, 2014 | Substantially Equivalent | VOLCANO CORPORATION |
| K132736 | ACCURO 3000 ULTRASOUND SCANNER | Mar 11, 2014 | Substantially Equivalent | RIVANNA MEDICAL, LLC |
| K140291 | VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS | Mar 07, 2014 | Substantially Equivalent | VOLCANO CORPORATION |
| K140126 | SONIC WINDOW | Mar 04, 2014 | Substantially Equivalent | ANALOGIC CORPORATION |
| K132346 | ULTRASOUND SCANNER PRO FOCUS 2202 | Jan 10, 2014 | Substantially Equivalent | B-K MEDICAL APS |
| K133641 | CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE | Dec 20, 2013 | Substantially Equivalent | VOLCANO CORPORATION |
| K123209 | SOFTVUE | Dec 19, 2013 | Substantially Equivalent | DELPHINUS MEDICAL TECHNOLOGIES, INC |
| K133142 | VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION | Nov 15, 2013 | Substantially Equivalent | VOLCANO CORPORATION |
| K132654 | ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | Sep 26, 2013 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. ULTRASOUND GRO |
| K131830 | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Sep 17, 2013 | Substantially Equivalent | EDAN INSTRUMENTS, INC. |
| K132228 | UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM | Aug 20, 2013 | Substantially Equivalent | SAMSUNG MEDISON CO., LTD |
| K131690 | M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM | Jul 24, 2013 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K131227 | PADSCAN HD SERIES BLADDER SCANNER | Jul 12, 2013 | Substantially Equivalent | CARENOSO TECHNOLOGY CO., LTD. |
| K131489 | TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION | Jun 25, 2013 | Substantially Equivalent | TRACTUS CORPORATION |
| K130944 | ISR'OBOT MONA LISA | Jun 07, 2013 | Substantially Equivalent | BIOBOT SURGICAL PTE LTD |
| K121243 | ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER | May 03, 2013 | Substantially Equivalent | MEDA CO. LTD. |
| K123806 | FIBROSCAN | Apr 05, 2013 | Substantially Equivalent | ECHOSENS |
| K130229 | PALM BLADDER SCANNER | Mar 20, 2013 | Substantially Equivalent | MIANYANG MEIKE ELECTRONIC EQUIPMENT CO., LTD. |
| K130243 | ILAB ULTRASOUND IMAGING SYSTEM | Mar 01, 2013 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K123349 | A-SCAN PLUS CONNECT | Jan 29, 2013 | Substantially Equivalent | ACCUTOME, INC. |
| K123535 | ILAB ULTRASOUND IMAGING SYSTEM | Jan 15, 2013 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K123898 | VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM | Jan 14, 2013 | Substantially Equivalent | VOLCANO CORPORATION |
| K123616 | PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM | Dec 21, 2012 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K123185 | DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM | Nov 02, 2012 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K122574 | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6 | Oct 12, 2012 | Substantially Equivalent | EDAN INSTRUMENTS, INC. |
| K121689 | VITASCAN LT SCANMASTER | Sep 19, 2012 | Substantially Equivalent | VITACON MEDICAL INC. |
| K121479 | AIM | Sep 13, 2012 | Substantially Equivalent | INNEROPTIC TECHNOLOGY, INC |
| K121422 | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM | Aug 16, 2012 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN |
| K121888 | E-CUBE 15 | Jul 26, 2012 | Substantially Equivalent | ALPINION MEDICAL SYSTEMS CO., LTD |
| K111818 | SONIXGPS NEEDLE SENSOR | Jun 13, 2012 | Substantially Equivalent | UltraSonix Medical Corporation |
| K121381 | VIEWFLEX XTRA ICE CATHETER | Jun 07, 2012 | Substantially Equivalent | ST. JUDE MEDICAL |
| K120882 | SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE | May 30, 2012 | Substantially Equivalent | BARD ACCESS SYSTEMS, INC. |
| K120201 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Apr 19, 2012 | Substantially Equivalent | GE VINGMED ULTRASOUND AS |
| K113304 | BLADDER SCANNER | Mar 23, 2012 | Substantially Equivalent | MEDA CO. LTD. |
| K112539 | CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE | Jan 30, 2012 | Substantially Equivalent | LEIKER REGULATORY & QUALITY CONSULTING |
| K113486 | VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM | Jan 27, 2012 | Substantially Equivalent | VOLCANO CORPORATION |
| K113632 | DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Jan 25, 2012 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD |
| K113680 | SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT | Dec 29, 2011 | Substantially Equivalent | SOMA ACCESS SYSTEMS LLC |
| K113153 | DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Nov 28, 2011 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K113156 | SONOSITE EDGE ULTRASOUND SYSTEM | Nov 15, 2011 | Substantially Equivalent | SONOSITE,INC. |
| K112022 | DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Sep 22, 2011 | Substantially Equivalent | ADVANCED INSTRUMENTATIONS, INC. |
| K111347 | ISROBOT MONA LISA | Aug 12, 2011 | Substantially Equivalent | BIOBOT SURGICAL PTE LTD |
| K111706 | VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM | Jul 15, 2011 | Substantially Equivalent | VOLCANO CORPORATION |
| K111435 | DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Jul 08, 2011 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K110688 | MYLABGOLD | Jun 02, 2011 | Substantially Equivalent | ESAOTE |
| K102253 | ECHO BLASTER | Mar 14, 2011 | Substantially Equivalent | TELEMED |
| K103148 | AIDA DIAGNOSTIC ULTRASOUND SYSTEM | Mar 11, 2011 | Substantially Equivalent | PANASONIC HEALTHCARE CO., LTD. |
| K102153 | MOBIUS ULTRASOUND IMAGING SYSTEM | Jan 20, 2011 | Substantially Equivalent | MOBISANTE, INC. |
| K103608 | I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND | Dec 27, 2010 | Substantially Equivalent | ELLEX, INC. |
| K102027 | AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM | Dec 22, 2010 | Substantially Equivalent | QUANTEL MEDICAL S.A. |
| K102393 | VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM | Nov 05, 2010 | Substantially Equivalent | GE MEDICAL SYSTEM ISRAEL LTD. |
| K102198 | COMPACT TOUCH STS | Nov 05, 2010 | Substantially Equivalent | QUANTEL MEDICAL S.A. |
| K102991 | M5 DIAGNOSTIC ULTRASOUND SYSTEM | Oct 22, 2010 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K101149 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Oct 13, 2010 | Substantially Equivalent | GE VINGMED ULTRASOUND AS |
| K101337 | A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM | Sep 30, 2010 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K101429 | ECO SUPERGEL | Sep 15, 2010 | Substantially Equivalent | CERACARTA SPA |
| K093466 | HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS | Jun 17, 2010 | Substantially Equivalent | HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K100363 | ULTRA DCI MODEL 5000 | May 21, 2010 | Substantially Equivalent | ULTRASOUND MEDICAL DEVICES, INC. |
| K094038 | COMPACT TOUCH | Apr 22, 2010 | Substantially Equivalent | QUANTEL S.A. |
| K100252 | MASTER-VU A-SCAN, MV4500 | Apr 09, 2010 | Substantially Equivalent | SONOMED, INC. |
| K093371 | MODEL DGH 6000 SCANMATE A | Apr 05, 2010 | Substantially Equivalent | DGH TECHNOLOGY, INC. |
| K093485 | VESISCAN | Mar 16, 2010 | Substantially Equivalent | LIFE-TECH, INC. |
| K100079 | DIGITAL ULTRASOUND SCANNER | Mar 01, 2010 | Substantially Equivalent | SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD |
| K092837 | OTI-SCAN 3000 | Dec 23, 2009 | Substantially Equivalent | OPKO INSTRUMENTATION, INC |
| K093488 | ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM | Nov 20, 2009 | Substantially Equivalent | ALOKA CO., LTD. |
| K092619 | ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER | Nov 13, 2009 | Substantially Equivalent | CIVCO |
| K092182 | VOYAGER COMPACT IMAGING SYSTEM | Oct 09, 2009 | Substantially Equivalent | Ardent Sound, Inc. |
| K090773 | CFI ULTRASOUND PROBE DRAPE | Sep 18, 2009 | Substantially Equivalent | CONTOUR FABRICATORS, INC. |
| K092140 | GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND | Aug 21, 2009 | Substantially Equivalent | GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. |
| K083728 | INVISION SYSTEM | Aug 12, 2009 | Substantially Equivalent | INNEROPTIC TECHNOLOGY, INC |
| K091518 | CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM | Jun 18, 2009 | Substantially Equivalent | MCUBE TECHNOLOGY CO., LTD. |
| K091374 | GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND | May 26, 2009 | Substantially Equivalent | GE MEDICAL SYSTEMS CHINA CO., LTD. |
| K090505 | SPEQ ULTRASOUND SYSTEM | May 07, 2009 | Substantially Equivalent | SIGNOSTICS PTY LTD |
| K090059 | IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM | Apr 30, 2009 | Substantially Equivalent | SASET (CHENGDU) INC. |
| K090214 | VERATHON INC. BLADDERSCAN BVM 9500 ULTRASOUND | Mar 13, 2009 | Substantially Equivalent | VERATHON INCORPORATED |
| K083061 | ELLEX INNOVATIVE IMAGING EYE CUBED V4 | Jan 09, 2009 | Substantially Equivalent | ELLEX, INC. |
| K081148 | SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER | Dec 22, 2008 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
| K082456 | VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 | Dec 01, 2008 | Substantially Equivalent | VERATHON INCORPORATED |
| K082543 | SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100 | Oct 14, 2008 | Substantially Equivalent | SONOCINE, INC. |
| K082229 | S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM | Oct 08, 2008 | Substantially Equivalent | VOLCANO CORPORATION |
| K082185 | GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 | Aug 15, 2008 | Substantially Equivalent | GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
| K080930 | MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS | Aug 07, 2008 | Substantially Equivalent | U-SYSTEM, INC. |
| K081873 | EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE | Jul 16, 2008 | Substantially Equivalent | SHENZHEN EMPEROR ELECTRONIC TECHNOLOGY CO. LTD. |
| K081781 | NUWAV | Jul 09, 2008 | Substantially Equivalent | LABORIE MEDICAL TECHNOLOGIES, CORP |
| K080223 | ZURA TEE SYSTEM | Jun 24, 2008 | Substantially Equivalent | IMACOR LLC |
| K081121 | MODIFICATION TO ACUSON X150 ULTRASOUND SYSTEM | Jun 04, 2008 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
| K081154 | ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 | May 23, 2008 | Substantially Equivalent | B-K MEDICAL APS |
| K081110 | SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM | May 16, 2008 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
| K080234 | TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO | Feb 14, 2008 | Substantially Equivalent | TERATECH CORP. |
| K080049 | VASCUVIEW ULTRASOUND SYSTEM | Jan 23, 2008 | Substantially Equivalent | ESCALON MEDICAL CORP. |
| K073196 | MASTER-VU | Dec 19, 2007 | Substantially Equivalent | SONOMED, INC. |
| K072676 | ACUSON X300 ULTRASOUND SYSTEM | Dec 18, 2007 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K072797 | GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND | Oct 17, 2007 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K072517 | ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3 | Sep 26, 2007 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K072210 | CHISON, MODEL 8300 | Aug 24, 2007 | Substantially Equivalent | CHISON MEDICAL IMAGING CO., LTD. |
| K071996 | MYLAB30, MODEL 7300 | Aug 03, 2007 | Substantially Equivalent | ESAOTE S.P.A. |
| K071156 | SOUNMED SD-2000 PLUS PORTABLE ULTRASOUND SCANNER | Jul 03, 2007 | Substantially Equivalent | SOUNMED, INC. |
| K071314 | SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS | May 22, 2007 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K071204 | SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6 | May 18, 2007 | Substantially Equivalent | C.R. BARD, INC. |
| K071217 | BLADDERSCAN BVI 9400 ULTRASOUND | May 17, 2007 | Substantially Equivalent | VERATHON INCORPORATED |
| K071134 | SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM | May 08, 2007 | Substantially Equivalent | SONOSITE,INC. |
| K070982 | CTS-7700 DIGITAL ULTRASOUND IMAGING SYSTEM | May 02, 2007 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
| K070943 | B-SCAN PLUS | Apr 19, 2007 | Substantially Equivalent | ACCUTOME ULTRASOUND, INC. |
| K070907 | INTERSON USB ULTRASOUND PROBE SYSTEM | Apr 17, 2007 | Substantially Equivalent | REGULATORY MANAGEMENT SERVICES |
| K070884 | POD B-SCAN | Apr 11, 2007 | Substantially Equivalent | STARFISH PRODUCT ENGINEERING INC. |
| K070526 | DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Mar 23, 2007 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K070477 | ORISON EMBRACE SYSTEM | Mar 09, 2007 | Substantially Equivalent | ORISON CORPORATION |
| K070077 | ULTRASOUND SCANNER PROFOCUS, MODEL 2202 | Mar 05, 2007 | Substantially Equivalent | B-K MEDICAL APS |
| K063472 | ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200 | Jan 31, 2007 | Substantially Equivalent | MEDA LTD. |
| K063433 | ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200 | Jan 29, 2007 | Substantially Equivalent | MEDA LTD. |
| K062571 | LONGPORT EPISCAN, MODEL-I-200 | Nov 21, 2006 | Substantially Equivalent | LONGPORT, INC. |
| K063085 | MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM | Nov 14, 2006 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K061215 | VOLCANO S51 FAMILY OF IMAGING SYSTEMS | Aug 10, 2006 | Substantially Equivalent | VOLCANO CORPORATION |
| K061755 | MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM | Aug 07, 2006 | Substantially Equivalent | ESAOTE EUROPE B.V. |
| K061641 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SARANO | Jul 14, 2006 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K061682 | GE VOLUSON E8 ULTRASOUND SYSTEM | Jul 12, 2006 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K060483 | VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM | Jun 23, 2006 | Substantially Equivalent | VOLCANO CORPORATION |
| K061083 | CTS-7700 | Jun 06, 2006 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
| K061189 | DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Jun 01, 2006 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K060949 | DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | May 04, 2006 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K053306 | IVIEW | Apr 19, 2006 | Substantially Equivalent | ONDEMANDSOFT |
| K060626 | VUMAX | Apr 11, 2006 | Substantially Equivalent | SONOMED, INC. |
| K060800 | SEEKER/SPARK ULTRASOUND SYSTEM | Apr 07, 2006 | Substantially Equivalent | Ardent Sound, Inc. |
| K053346 | MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900 | Dec 09, 2005 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K053325 | MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 | Dec 07, 2005 | Substantially Equivalent | MEDIWATCH LTD |
| K052348 | IN VISION GOLD WITH SPIN VISION, MODEL 891 SV | Dec 02, 2005 | Substantially Equivalent | VOLCANO CORPORATION |
| K052355 | AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS | Sep 14, 2005 | Substantially Equivalent | U-SYSTEMS, INC. |
| K051920 | VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001 | Aug 19, 2005 | Substantially Equivalent | VOLCANO CORPORATION |
| K052113 | DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Aug 09, 2005 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K051851 | AVISO OPHTHALMIC ULTRASOUND SYSTEM | Aug 03, 2005 | Substantially Equivalent | QUANTEL MEDICAL |
| K051500 | FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A | Jun 17, 2005 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K051304 | ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM | Jun 03, 2005 | Substantially Equivalent | SCIENCE SURGICAL CORPORATION |
| K050980 | ULTRASONIC BIO-MICROSCOPE, MODEL P60 | May 26, 2005 | Substantially Equivalent | PARADIGM MEDICAL INDUSTRIES, INC. |
| K050552 | PACHPEN PACHYMETER, MODEL 24-5100 | Mar 28, 2005 | Substantially Equivalent | ACCUTOME, INC. |
| K050551 | VOYAGER PERSONAL IMAGING DEVICE | Mar 22, 2005 | Substantially Equivalent | Ardent Sound, Inc. |
| K043189 | SONALIS, MODEL 2000 | Feb 09, 2005 | Substantially Equivalent | 3G ULTRASOUND, INC. |
| K050167 | CHISON 600M WITH C60 CONVEX PROBE, L700 LINEAR PROBE | Feb 08, 2005 | Substantially Equivalent | CHISON MEDICAL IMAGING CO., LTD. |
| K043563 | DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Jan 11, 2005 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K042620 | SONATA 3-D IMAGING ACCESSORY, MODEL 3DS | Dec 23, 2004 | Substantially Equivalent | TETRAD CORP. |
| K043287 | PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 | Dec 10, 2004 | Substantially Equivalent | MICRO MEDICAL DEVICES, INC. |
| K043275 | OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER | Dec 09, 2004 | Substantially Equivalent | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| K043078 | NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A | Nov 17, 2004 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K042250 | SENSATOUCH | Nov 12, 2004 | Substantially Equivalent | ALUNA MANAGEMENT CO., LTD. |
| K042752 | ACCUPACH V | Nov 10, 2004 | Substantially Equivalent | ACCUTOME ULTRASOUND, INC. |
| K042188 | VOLCANO THERAPEUTICS, INC. VOLCANO IVUS SYSTEM | Nov 10, 2004 | Substantially Equivalent | VOLCANO THERAPEUTICS, INC. |
| K042831 | ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER) | Oct 28, 2004 | Substantially Equivalent | REICHERT INC. |
| K042833 | SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS | Oct 27, 2004 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K042540 | PHILIPS IU22 ULTRASOUND SYSTEM | Oct 04, 2004 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K041639 | TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM | Sep 02, 2004 | Substantially Equivalent | ENVISIONEERING, LLC. |
| K041947 | I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND | Aug 16, 2004 | Substantially Equivalent | INNOVATIVE IMAGING, INC. |
| K041455 | SSI-600/SSI-800 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Jun 10, 2004 | Substantially Equivalent | SONOSCAPE COMPANY LIMITED |
| K040652 | VUE 100 ULTRASOUND IMAGING SYSTEM | May 17, 2004 | Substantially Equivalent | MOBILSONIC, INC. |
| K040668 | E-Z SCAN AB5500+ | Apr 13, 2004 | Substantially Equivalent | SONOMED, INC. |
| K040719 | ALOKA MODEL SSD-4000 DIAGNOSTIC ULTRASOUND SYSTEM W/OPTIONAL SONOREAL 3D SYSTEM ACCESSORY | Mar 26, 2004 | Substantially Equivalent | ALOKA CO., LTD. |
| K040502 | SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS | Mar 09, 2004 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K033906 | PORTASCAN BLADDER SCANNER, MODEL PA00146 | Dec 24, 2003 | Substantially Equivalent | MEDIWATCH PLC |
| K033604 | TRINGA ULTRASOUND IMAGING SYSTEM, MODEL 50L | Dec 15, 2003 | Substantially Equivalent | PIE MEDICAL |
| K033385 | DGH 55 HANDHELD PACHYMETER (PACHMATE) | Nov 07, 2003 | Substantially Equivalent | DGH TECHNOLOGY, INC. |
| K032956 | ACCUSONIC A-SCAN MODEL, 24-4000 | Oct 10, 2003 | Substantially Equivalent | ACCUTOME, INC. |
| K032875 | ALOKA MODEL SSD-5500 V6.0 ULTRASOUND SYSTEM | Sep 30, 2003 | Substantially Equivalent | ALOKA CO. LTD USA |
| K032640 | FULL FIELD BREAST IMAGING (FFBU) DIAGNOSTIC ULTRASOUND SYSTEM | Sep 11, 2003 | Substantially Equivalent | U-SYSTEMS, INC. |
| K032135 | SITE-RITE IV ULTRASOUND SYSTEM | Jul 21, 2003 | Substantially Equivalent | DYMAX CORP. |
| K023430 | UF BRACHYTHERAPY STAND | Jun 24, 2003 | Substantially Equivalent | UNIVERSITY OF FLORIDA |
| K031391 | HF MODULE WITH TRANSDUCERS | Jun 20, 2003 | Substantially Equivalent | OPHTHALMIC TECHNOLOGIES, INC. |
| K030770 | OTI SCAN WITH TRANSDUCERS | Mar 27, 2003 | Substantially Equivalent | OPHTHALMIC TECHNOLOGIES, INC. |
| K030763 | DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM | Mar 26, 2003 | Substantially Equivalent | DIAGNOSTIC ULTRASOUND CORP. |
| K030610 | POD PAC-20M | Mar 21, 2003 | Substantially Equivalent | PORTABLE OPHTHALMIC DEVICES, INC. |
| K024114 | A-SCAN 100 | Jan 10, 2003 | Substantially Equivalent | OPHTHALMIC TECHNOLOGIES, INC. |
| K022928 | HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS | Dec 11, 2002 | Substantially Equivalent | HUDSON DIAGNOSTIC IMAGING LLC |
| K023473 | SONOREAL 3D | Nov 20, 2002 | Substantially Equivalent | BIO MEDI COM |
| K023457 | ULTRASOUND SCANNER, TYPE 1101 | Nov 01, 2002 | Substantially Equivalent | B-K MEDICAL A/S |
| K021333 | ARTEMIS | Oct 08, 2002 | Substantially Equivalent | ULTRALINK, LLC. |
| K022153 | BLADDERSCAN BVI 6100 | Aug 15, 2002 | Substantially Equivalent | DIAGNOSTIC ULTRASOUND CORP. |
| K020668 | ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124 | Jul 10, 2002 | Substantially Equivalent | ALOKA CO., LTD. |
| K021683 | CINESCAN S | Jun 21, 2002 | Substantially Equivalent | QUANTEL MEDICAL |
| K020561 | SONO-SCAN, SONO-SCAN PRO, CARDIO SCAN | May 09, 2002 | Substantially Equivalent | TOMTEC IMAGING SYSTEMS, GMBH |
| K020876 | ECHOSCAN, MODEL US-1800 | May 03, 2002 | Substantially Equivalent | NIDEK, INC. |
| K020112 | 50S TRINGA ULTRASOUND IMAGING SYSTEM | Apr 19, 2002 | Substantially Equivalent | PIE MEDICAL |
| K020151 | UD-1000 ULTRASONIC A/B SCANNER | Apr 10, 2002 | Substantially Equivalent | TOMEY CORP. USA |
| K012803 | AL-2000 COMBINED BIOMETER AND PACHYMETER | Apr 08, 2002 | Substantially Equivalent | TOMEY CORP. |
| K013088 | ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS | Apr 04, 2002 | Substantially Equivalent | ECHOTECH 3D IMAGING SYSTEMS, INC. |
| K020068 | SONOREAL 3D SYSTEM | Mar 04, 2002 | Substantially Equivalent | BIO MEDI COM |
| K012727 | HUMPHREY OCT3 | Jan 31, 2002 | Substantially Equivalent | CARL ZEISS OPHTHALMIC SYSTEMS, INC. |
| K014206 | LOGIQBOOK | Jan 16, 2002 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K013327 | CTS-415 | Dec 14, 2001 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
| K013633 | SSA-770A, APLIO ULTRASOUND SYSTEM | Nov 13, 2001 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K013142 | DIASUS | Oct 05, 2001 | Substantially Equivalent | DYNAMIC IMAGING LTD. |
| K012772 | CTS-485 ULTRASOUND IMAGING SYSTEM | Oct 01, 2001 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
| K012084 | SONOREAL 3D | Sep 26, 2001 | Substantially Equivalent | BIO MEDI COM |
| K012887 | SA6000II DIAGNOSTIC ULTRASOUND SYSTEM | Sep 12, 2001 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K012253 | SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM | Aug 30, 2001 | Substantially Equivalent | ALOKA CO., LTD. |
| K012560 | GE LOGIQ A100 MP, MODEL 2272413 | Aug 23, 2001 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K010950 | CYPRESS SYSTEM | Jun 27, 2001 | Substantially Equivalent | ACUSON CORP. |
| K011095 | MODEL I0-3DUIMS 3D ULTRASOUND MANAGEMENT SYSTEM | Jun 13, 2001 | Substantially Equivalent | IODP SA |
| K011417 | ULTRASOUND SCANNER, TYPE 2102 | Jun 08, 2001 | Substantially Equivalent | B-K MEDICAL A/S |
| K011252 | EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM | May 30, 2001 | Substantially Equivalent | HITACHI MEDICAL CORP. |
| K003890 | VHF ULTRASONIC ARC-SCAN SYSTEM | May 22, 2001 | Substantially Equivalent | ULTRALINK, LLC. |
| K003725 | 240 PARUS ULTRASOUND IMAGING SYSTEMS, MODEL 240 PARUS | Mar 01, 2001 | Substantially Equivalent | PIE MEDICAL |
| K003672 | MEDGE PLATFORMS SONOCUBIC 3D ULTRASOUND SOFTWARE | Feb 22, 2001 | Substantially Equivalent | MEDGE PLATFORMS, INC. |
| K003936 | PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING | Feb 14, 2001 | Substantially Equivalent | TOMTEC IMAGING SYSTEMS, GMBH |
| K003041 | ULTRASOUND SCANNER TYPE 2101 | Feb 07, 2001 | Substantially Equivalent | B-K MEDICAL A/S |
| K003292 | 260 CORVUS | Jan 05, 2001 | Substantially Equivalent | PIE MEDICAL |
| K003141 | UBM PLUS, MODEL P45 | Dec 05, 2000 | Substantially Equivalent | PARADIGM MEDICAL INDUSTRIES, INC. |
| K002807 | 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING | Dec 01, 2000 | Substantially Equivalent | ACUSON CORP. |
| K002357 | 100 S AND 100 LC AND 485 ANSER ULTRASOUND IMAGING SYSTEMS | Nov 09, 2000 | Substantially Equivalent | PIE MEDICAL |
| K003121 | MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS | Oct 20, 2000 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K002085 | ULTRASOUND SCANNER, TYPE 1101 | Aug 01, 2000 | Substantially Equivalent | B & K MEDICAL A/S |
| K993674 | POCKET ULTRASONIC PACHYMETER | Jul 13, 2000 | Substantially Equivalent | QUANTEL MEDICAL |
| K000960 | BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900 | May 26, 2000 | Substantially Equivalent | BARZELL-WHITMORE MAROON BELLS, INC. |
| K000681 | AU5, AU6 | May 03, 2000 | Substantially Equivalent | BIOSOUND ESAOTE, INC. |
| K000320 | SONOS AIRES 600 (SA-600) | May 02, 2000 | Substantially Equivalent | KPI ULTRASOUND, LLC. |
| K000516 | GE LOGIQ 700 | Apr 19, 2000 | Substantially Equivalent | GE MEDICAL SYSTEMS, INC. |
| K000571 | GE LOGIQ 700 | Apr 18, 2000 | Substantially Equivalent | GE MEDICAL SYSTEMS |
| K994385 | BABY FACE | Mar 16, 2000 | Substantially Equivalent | SONORA MEDICAL SYSTEMS |
| K000695 | GE DOLPHIN DIAGNOSTIC ULTRASOUND SYSTEM, ULTRASONIC PULSED DOPPLER IMAGING SYSTEM | Mar 16, 2000 | Substantially Equivalent | GE MEDICAL SYSTEMS, INC. |
| K000554 | POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR POCKET | Mar 14, 2000 | Substantially Equivalent | QUANTEL MEDICAL |
| K000567 | ULTRASOUND SCANNER TYPE 2102 | Mar 09, 2000 | Substantially Equivalent | B & K MEDICAL A/S |
| K993978 | PR3 ULTRASOUND SYSTEM | Feb 10, 2000 | Substantially Equivalent | CAROLINA MEDICAL, INC. |
| K000030 | SONOACE 600 DIAGNOSTIC ULTRASOUND SYSTEM | Jan 19, 2000 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K993624 | SITE-RITE 3 ULTRASOUND SYSTEM | Nov 10, 1999 | Substantially Equivalent | DYMAX CORP. |
| K992505 | TERATECH, MODEL 2000 IMAGING IMAGING | Nov 10, 1999 | Substantially Equivalent | TERATECH CORP. |
| K993398 | ECHO VIEW, EASY VIEW, OMNI VIEW | Nov 05, 1999 | Substantially Equivalent | TOMTEC IMAGING SYSTEMS, GMBH |
| K993394 | ECHO SCAN, EASY SCAN | Nov 05, 1999 | Substantially Equivalent | TOMTEC IMAGING SYSTEMS, GMBH |
| K993365 | GE LOGIQ 700 WITH HARMONIC IMAGING MODIFICATION | Nov 05, 1999 | Substantially Equivalent | GE MEDICAL SYSTEMS, INC. |
| K993364 | GE LOGIQ 700 WITH CODED EXCITATION MODIFICATION | Nov 05, 1999 | Substantially Equivalent | GE MEDICAL SYSTEMS, INC. |
| K993517 | COMBISON 530D/VOLUSON 530D, TISSUE HARMONIC IMAGING (THI) OPTION | Nov 02, 1999 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K992580 | FETAL ASSESSMENT CAP | Oct 18, 1999 | Substantially Equivalent | ACUSON CORP. |
| K990401 | FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER | Oct 15, 1999 | Substantially Equivalent | FUKUDA DENSHI USA, INC. |
| K992378 | DIAGNOSTIC ULTRASOUND, MODEL 1.0 | Sep 29, 1999 | Substantially Equivalent | VOLUMETRICS MEDICAL IMAGING, INC. |
| K993069 | GE DIASONICS GATEWAY AND GATEWAY FX | Sep 22, 1999 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K992761 | SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM | Sep 01, 1999 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K992470 | ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM | Aug 23, 1999 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K992046 | SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM | Aug 13, 1999 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K991937 | ULTRASOUND SCANNER, MODEL TYPE 2101 | Jul 30, 1999 | Substantially Equivalent | B & K MEDICAL A/S |
| K991469 | AWARE PAD | Jul 20, 1999 | Substantially Equivalent | AAC CONSULTING GROUP, INC. |
| K992208 | GE LOGIQ 200 MD DIAGNOSTIC ULTRASOUND SYSTEM | Jul 12, 1999 | Substantially Equivalent | GE MEDICAL SYSTEMS, INC. |
| K990198 | AMIB7 | Jun 29, 1999 | Substantially Equivalent | ALLIANCE MEDICAL, INC. |
| K990238 | LONGPORT MODEL LDS -1 | Jun 23, 1999 | Substantially Equivalent | LONGPORT, INC. |
| K991671 | HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM | Jun 18, 1999 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K991842 | SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING | Jun 11, 1999 | Substantially Equivalent | GE VINGMED ULTRASOUND |
| K991611 | GE LOGIQ 500 | Jun 09, 1999 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K991710 | SSA-370A/POWERVISION 6000 | Jun 03, 1999 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K990560 | LIFE IMAGING SYSTEMS, MODEL L3DI | May 20, 1999 | Substantially Equivalent | LIFE IMAGING SYSTEMS, INC. |
| K984161 | CTS-310(B) | May 05, 1999 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
| K990248 | DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION | Apr 16, 1999 | Substantially Equivalent | DICOMIT IMAGING SYSTEMS CORP. |
| K983879 | ALOKA SSD-900 DIAGNOSTIC ULTRASOUND SYSTEM | Mar 22, 1999 | Substantially Equivalent | ALOKA CO., LTD. |
| K983945 | CORTEX DERMASCAN C ULTRASONIC SYSTEM | Mar 17, 1999 | Substantially Equivalent | CORTEX TECHNOLOGY APS |
| K984382 | ACCU GUIDE | Mar 05, 1999 | Substantially Equivalent | TAYMAN MEDICAL, INC. |
| K990490 | SSA-320A JUST VISION 200/ SSA-325A JUST VISION | Mar 02, 1999 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K990226 | GE LOGIQ700 DIAGNOSTIC ULTRASOUND SYSTEM WITH B-FLOW | Feb 09, 1999 | Substantially Equivalent | GE MEDICAL SYSTEMS, INC. |
| K982840 | BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE ADAPTER & BSC SONICATH ULTRA ULTRASOUND IMAGING | Nov 09, 1998 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K981528 | SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM | Oct 28, 1998 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K982444 | 7250 ULTRASOUND IMAGING SYSTEM | Oct 06, 1998 | Substantially Equivalent | BIOSOUND ESAOTE, INC. |
| K982800 | ECTON LYNX ULTRASOUND SYSTEM | Sep 22, 1998 | Substantially Equivalent | ECTON, INC. |
| K980423 | SONOPSY LA SYSTEM | Aug 07, 1998 | Substantially Equivalent | NEOVISION CORP. |
| K974457 | SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T | Jul 14, 1998 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K981293 | 7200 ULTRASOUND IMAGING SYSTEM | Jun 30, 1998 | Substantially Equivalent | BIOSOUND ESAOTE, INC. |
| K965223 | RESOLVE OPTION FOR THE ORACLE IN VISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | Jun 29, 1998 | Substantially Equivalent | ENDOSONICS CORP. |
| K974880 | PERCEPTION GPS-RST DIAGNOSTIC ULTRASOUND SYSTEM | Jun 08, 1998 | Substantially Equivalent | PERCEPTION, INC. |
| K981626 | SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM | May 27, 1998 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K980687 | SONOS 5500 ULTRASOUND IMAGING SYSTEM | May 22, 1998 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K981404 | FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 | May 20, 1998 | Substantially Equivalent | FUKUDA DENSHI USA, INC. |
| K981510 | SONOACE 6000/ ULTRAMARK 400 | May 08, 1998 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K981505 | COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM | May 08, 1998 | Substantially Equivalent | SONOSITE,INC. |
| K980308 | ECHOTECH 3D FREESCAN | May 06, 1998 | Substantially Equivalent | ECHOTECH 3D IMAGING SYSTEMS GMBH |
| K980851 | GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028 | Apr 22, 1998 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K980860 | HDI 1000 DIAGNOSTIC ULTRASOUND SYSTEM | Apr 02, 1998 | Substantially Equivalent | ATLANTIS DIAGNOSTICS INTL., INC. |
| K973802 | SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM | Mar 04, 1998 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K974522 | 3D I-SCAN | Feb 25, 1998 | Substantially Equivalent | OPHTHALMIC TECHNOLOGIES, INC. |
| K974432 | ULTRAGUIDE 1000 | Feb 09, 1998 | Substantially Equivalent | ULTRAGUIDE LTD. |
| K973767 | HARMONIC IMAGING WITH CONTRAST | Dec 23, 1997 | Substantially Equivalent | ACUSON CORP. |
| K970901 | GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 22, 1997 | Substantially Equivalent | GE MEDICAL SYSTEMS |
| K972192 | PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM | Dec 17, 1997 | Substantially Equivalent | PERCEPTION, INC. |
| K971528 | ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (ENDOSCOPY) | Dec 12, 1997 | Substantially Equivalent | FUJINON, INC. |
| K973450 | SENSOR PAD | Nov 14, 1997 | Substantially Equivalent | INVENTIVE PRODUCTS, INC. |
| K972973 | PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM | Oct 15, 1997 | Substantially Equivalent | PERCEPTION, INC. |
| K964617 | GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM | Oct 03, 1997 | Substantially Equivalent | GE MEDICAL SYSTEMS |
| K963290 | COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM | Aug 06, 1997 | Substantially Equivalent | ENDOSONICS CORP. |
| K970508 | ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM | Aug 04, 1997 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K963068 | CTS-200 WITH EZU-PL21 TRANSDUCER | May 29, 1997 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
| K963065 | CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS | May 29, 1997 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
| K962142 | SONOLINE VERSA 555 DIAGNOSTIC ULTRASOUND SYSTEM | May 29, 1997 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K961229 | HR12000 ULTRASOUND SYSTEM | May 29, 1997 | Substantially Equivalent | INTERNATIONAL ULTRASOUND CORP. |
| K962882 | SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM | Apr 24, 1997 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K963863 | JANUS I | Apr 21, 1997 | Substantially Equivalent | 3D ULTRASOUND, INC. |
| K970156 | IMEX FUTURALDOP PRO | Apr 04, 1997 | Substantially Equivalent | IMEX MEDICAL SYSTEMS, INC. |
| K961459 | LEVEL 10 HDI | Mar 26, 1997 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K963706 | PHILIPS SONO DIAGNOST 800 | Mar 19, 1997 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K963315 | VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE | Mar 17, 1997 | Substantially Equivalent | VINGMED SOUND, INC. |
| K961073 | ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE) | Feb 19, 1997 | Substantially Equivalent | ATLANTIS DIAGNOSTICS INTL., INC. |
| K940942 | COMBISON 530 DIAGNOSTIC ULTRASOUND SCANNER | Feb 19, 1997 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K955543 | ULTRASOUND SYSTEM MODEL UF-3500 | Feb 11, 1997 | Substantially Equivalent | FUKUDA DENSHI USA, INC. |
| K962662 | VINGMED SOUND COLOR FLOW MAPPING SYSTEM | Jan 02, 1997 | Substantially Equivalent | DIASONICS, INC. |
| K963807 | TOMTEC ECHO-SCAN | Dec 18, 1996 | Substantially Equivalent | TOMTEC IMAGING SYSTEMS, INC. |
| K963274 | V-LINK 3.2 FOR WINDOWS | Oct 31, 1996 | Substantially Equivalent | KOVEN TECHNOLOGY, INC. |
| K961833 | SONOLINE ELEGRA WITH SIESCAPE FEATURE | Oct 29, 1996 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K963585 | BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000 | Oct 01, 1996 | Substantially Equivalent | DIAGNOSTIC ULTRASOUND CORP. |
| K960700 | LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM | Aug 28, 1996 | Substantially Equivalent | GE MEDICAL SYSTEMS |
| K961116 | FIRST BEAT/CARDIO BEAT/CALC | Aug 08, 1996 | Substantially Equivalent | MEDASONICS, INC. |
| K960765 | MENTOR ADVENT A/B SYSTEM | Aug 08, 1996 | Substantially Equivalent | MENTOR OPHTHALMICS, INC. |
| K951976 | ECHO. AKHO | Jul 26, 1996 | Substantially Equivalent | ALLIANCE MEDICAL, INC. |
| K961029 | KILTEX PROBE COVER | Jul 25, 1996 | Substantially Equivalent | KILTEX CORP. |
| K962308 | EUB-905 | Jul 17, 1996 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K954884 | PEDIATRIC MULTIPLANE TRANSESOPHAGEAL PROBE (PMPTE-PROBE), TN100065 | May 28, 1996 | Substantially Equivalent | VINGMED SOUND, INC. |
| K955840 | BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 | May 24, 1996 | Substantially Equivalent | DIAGNOSTIC ULTRASOUND CORP. |
| K946349 | STENODOC | May 24, 1996 | Substantially Equivalent | SPECS USA, INC. |
| K951449 | MODEL KM-25 | May 20, 1996 | Substantially Equivalent | KOVEN TECHNOLOGY, INC. |
| K941593 | DIAGNOSTIC ULTRASONIC TRANSDUCER | May 17, 1996 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K960622 | I-SCAN | May 13, 1996 | Substantially Equivalent | OPHTHALMIC TECHNOLOGIES, INC. |
| K950330 | DIGITAL IMAGE ACQUISITION SYSTEM | May 07, 1996 | Substantially Equivalent | INTERNATIONAL IMAGING ELECTRONICS |
| K951994 | OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER | Apr 15, 1996 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K953530 | DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A | Apr 08, 1996 | Substantially Equivalent | BIOSOUND, INC. |
| K950157 | SIEMENS Q64XXX | Apr 05, 1996 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K955942 | BLADDERSCAN BVI 5000 | Mar 15, 1996 | Substantially Equivalent | DIAGNOSTIC ULTRASOUND CORP. |
| K953752 | RT55 DIAGNOSTIC ULTRASOUND SYSTEM | Mar 15, 1996 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K953773 | 6.5 MHZ ENDORECTAL CONVEX ARRAY (10R) PROBE | Mar 14, 1996 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K953673 | ECLIPSE PROBE COVER | Mar 14, 1996 | Substantially Equivalent | PARKER LABORATORIES, INC. |
| K952540 | SONOS IMAGING SYSTEM (2000/2500 & 1000/1500) | Mar 11, 1996 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K950943 | ULTRA EASE | Mar 07, 1996 | Substantially Equivalent | LECTEC CORP. |
| K953634 | SHIMASONIC SDU-350 ELECTRONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM | Feb 13, 1996 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K943315 | ULTRASOUND SCANNER 2002 | Feb 09, 1996 | Substantially Equivalent | B&K MEDICAL |
| K951999 | HOLOPSY SYSTEM | Jan 05, 1996 | Substantially Equivalent | NEOVISION CORP. |
| K952551 | JANUS I | Dec 11, 1995 | Substantially Equivalent | 3D ULTRASOUND, INC. |
| K955094 | EXAMINATION PAD | Nov 09, 1995 | Substantially Equivalent | INVENTIVE PRODUCTS, INC. |
| K942243 | IMEX 8000 PERSONAL CASCULAR LAB | Nov 03, 1995 | Substantially Equivalent | IMEX MEDICAL SYSTEMS, INC. |
| K945795 | EUB-555A+ | Oct 27, 1995 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K953468 | SONOGEL | Oct 17, 1995 | Substantially Equivalent | SONOTECH, INC. |
| K946179 | SIEMENS SONOLINE 4XX | Oct 03, 1995 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K950276 | MICROSOUND 6.6F DIAGNOSTIC IMAGING CATHETER MODEL 50302, INTRAVASCULAR ULTRASOUND IMAGING SYSTEM | Sep 22, 1995 | Substantially Equivalent | ENDOSONICS CORP. |
| K936024 | ULTRASOUND SCANNER 2001 | Aug 22, 1995 | Substantially Equivalent | B & K MEDICAL A/S |
| K941322 | ECHO-SCAN | Jul 27, 1995 | Substantially Equivalent | TOMOGRAPHIC TECH |
| K951925 | DICOMIT | Jul 12, 1995 | Substantially Equivalent | DICOMIT IMAGING SYSTEMS CORP. |
| K944597 | GRAHAM-FIELD ULTRASOUND SCANNING GEL | Jun 21, 1995 | Substantially Equivalent | CHESTER LABS, INC. |
| K926363 | MULTI-DOP S | Jun 19, 1995 | Substantially Equivalent | DANTEC MEDICAL, INC. |
| K931801 | MULTI-DOP X | Jun 14, 1995 | Substantially Equivalent | DANTEC MEDICAL, INC. |
| K944485 | 4000 AU ULTRASOUND IMAGING SYSTEM | May 24, 1995 | Substantially Equivalent | BIOSOUND, INC. |
| K944004 | VISIONS 2.9F ULTRASONIC IMAGING CATHETER (MODEL 84300) | May 04, 1995 | Substantially Equivalent | ENDOSONICS CORP. |
| K943303 | PVK-357AT | Feb 03, 1995 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K943113 | SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM | Feb 01, 1995 | Substantially Equivalent | ALOKA CO., LTD. |
| K934139 | TOMTEC ECHO-VIEW | Jan 25, 1995 | Substantially Equivalent | TOMTEC TOMOGRAPHIC TECHNOLOGIES GMBH |
| K925582 | MEDISON 4800 | Dec 27, 1994 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K923273 | AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 27, 1994 | Substantially Equivalent | ACOUSTIC IMAGING TECHNOLOGIES CORP. |
| K944523 | HUMPHREY OCT (OPTICAL COHERENCE TOMOGRAPHY) SCANNER | Dec 15, 1994 | Substantially Equivalent | HUMPHREY, INC. |
| K940151 | ULTRASOUND PROBE DRAPE | Nov 14, 1994 | Substantially Equivalent | HYDRO-MED PRODUCTS, INC. |
| K931021 | SHIMASONIC SDU-400 ELECTRONIC LINEAR/CONVEX D.U.S. | Nov 14, 1994 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K930964 | ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE) | Oct 26, 1994 | Substantially Equivalent | ACUSON CORP. |
| K925999 | SWEMED NEEDLE GUIDE | Oct 03, 1994 | Substantially Equivalent | SWEMED LAB INTL. |
| K943634 | HP 77010CF | Sep 30, 1994 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K931909 | CLEAR IMAGE STERILE DIAGNOSTIC ULTRSOUND GEL | Sep 29, 1994 | Substantially Equivalent | SONOMED TECHNOLOGY, INC. |
| K931908 | SONOQUICK ULTRASOUND GEL | Sep 29, 1994 | Substantially Equivalent | SONOMED TECHNOLOGY, INC. |
| K933320 | CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT | Aug 17, 1994 | Substantially Equivalent | CARDIOMETRICS, INC. |
| K926332 | DIAGNOSTIC ULTRASOUND SYSTEM, TYPE 3535, MODIFIED | Jun 28, 1994 | Substantially Equivalent | B&K MEDICAL |
| K933056 | DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED | Jun 24, 1994 | Substantially Equivalent | B&K MEDICAL |
| K934205 | SEARCH-SONIC | Jun 21, 1994 | Substantially Equivalent | ALTANA, INC. |
| K926209 | EUB-555 | Jun 03, 1994 | Substantially Equivalent | HITACHI MEDICAL CORP. |
| K933747 | CAPASEE | May 13, 1994 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K930768 | ORION DIAGNOSTIC ULTRASOUND SYSTEM | Mar 15, 1994 | Substantially Equivalent | GE MEDICAL SYSTEMS |
| K930278 | STORZ COMPUSCAN AB | Feb 09, 1994 | Substantially Equivalent | STORZ |
| K934908 | FULL VIEW DIGITAL STORAGE SYSTEM | Jan 28, 1994 | Substantially Equivalent | INTERNATIONAL IMAGING ELECTRONICS |
| K934311 | INTRASCAN(R) MINI-PACS | Dec 13, 1993 | Substantially Equivalent | MARKCARE MEDICAL SYSTEMS, INC. |
| K924184 | CVI-Q(TM) OPTION FOR P700 | Dec 10, 1993 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS, INC. |
| K924432 | MEDISON 1500 | Nov 24, 1993 | Substantially Equivalent | MEDISON CO., LTD. |
| K923211 | DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE | Nov 08, 1993 | Substantially Equivalent | ZEISS HUMPHREY SYSTEM |
| K930579 | MEDISON 88P DIAGNOSTIC ULTRASOUND IMAGING SYTEM | Nov 03, 1993 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K926252 | CATHSCANNER II INTRAVASCULAR ULTRASONIC IMAGING SY | Oct 25, 1993 | Substantially Equivalent | ENDOSONICS CORP. |
| K925627 | ADDITIONAL FEATURES ESI-3000 ULTRASOUND UNIT | Oct 08, 1993 | Substantially Equivalent | ELSCINT, INC. |
| K924079 | CFM-800 COLOR FLOW MAPPING SYSTEM | Sep 28, 1993 | Substantially Equivalent | DIASONICS, INC. |
| K926251 | B-SCAN OPTHALMIC ULTRASOUND IMAGING SYSTEM | Sep 14, 1993 | Substantially Equivalent | BIOVISION, INC. |
| K922208 | FUKUDA DENSHI MODEL UF-4500 | Aug 30, 1993 | Substantially Equivalent | FUKUDA DENSHI USA, INC. |
| K930051 | FATHOM CMP-1000 | Jul 20, 1993 | Substantially Equivalent | FATHOM ENT., INC. |
| K926009 | MATRIX CCM 600 | Jul 20, 1993 | Substantially Equivalent | HERAEUS KULZER, INC. |
| K925354 | COMBISON(R) 311 | Jul 08, 1993 | Substantially Equivalent | KRETZTECHNIK AG |
| K925965 | PICTURE ARCHIVING AND COMMUNICATION SYSTEMS | Jun 14, 1993 | Substantially Equivalent | ADVANCED LIGHT IMAGING TECHNOLOGIES LTD. |
| K924231 | INTERSPEC APOGEE CLA | Jun 14, 1993 | Substantially Equivalent | INTERSPEC, INC. |
| K930324 | EZ MOVER | Jun 11, 1993 | Substantially Equivalent | PRIME IDEAS, INC. |
| K923246 | SONACE 2000 | May 20, 1993 | Substantially Equivalent | MEDISON CO., LTD. |
| K925646 | SSD-2000 DIAG. ULTRASOUND SYS.&UST-979-3.5 TRANS. | Feb 12, 1993 | Substantially Equivalent | ALOKA CO., LTD. |
| K924458 | AI5200 DIAG ULTRA SOUND SYST INCLUD 7.5 & 10.0 MHZ | Jan 21, 1993 | Substantially Equivalent | ACOUSTIC IMAGING TECHNOLOGIES CORP. |
| K924126 | EUB-405 | Dec 10, 1992 | Substantially Equivalent | HITACHI MEDICAL SYSTEMS AMERICA, INC. |
| K924311 | SONOMED 4000P ULTRASONIC PACHYMETER | Dec 08, 1992 | Substantially Equivalent | SONOMED, INC. |
| K923269 | CONVEX AND LINEAR ARRAY TRANSDUCERS | Dec 03, 1992 | Substantially Equivalent | ALOKA CO., LTD. |
| K921705 | ULTRASONIC PACHYMETER | Nov 16, 1992 | Substantially Equivalent | PRECISION CORNEAL INSTRUMENTS |
| K920906 | DGH-500 PACHYMETER | Nov 02, 1992 | Substantially Equivalent | DGH TECHNOLOGY, INC. |
| K922605 | TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603 | Oct 20, 1992 | Substantially Equivalent | BIODAN MEDICAL SYSTEMS, LTD. |
| K922604 | DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE | Oct 20, 1992 | Substantially Equivalent | BIODAN MEDICAL SYSTEMS, LTD. |
| K904070 | COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A | Oct 09, 1992 | Substantially Equivalent | KRETZTECHNIK AG |
| K921426 | ULTRA PCI | Oct 05, 1992 | Substantially Equivalent | ADVANCED MEDICAL PRODUCTS, INC. |
| K922647 | COLOR DISKSTORE | Aug 11, 1992 | Substantially Equivalent | CAMTRONICS, LTD. |
| K915715 | CINE RECALL FUNCTION/OPUS 1 REAL TIME SCANNER | Jul 02, 1992 | Substantially Equivalent | AUSONICS PTY LTD. |
| K914945 | DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535, MODIFIED | Jun 26, 1992 | Substantially Equivalent | BRUEL & KJAER INDUSTRI A/S |
| K921670 | ACUSON IMAGE MANAGEMENT SYSTEM | Jun 25, 1992 | Substantially Equivalent | ACUSON CORP. |
| K920373 | MAESTRO DIGITAL VIDEO SYSTEM | Jun 24, 1992 | Substantially Equivalent | INTERNATIONAL IMAGING ELECTRONICS |
| K920374 | ALOKA 650CL DIAGNOSTIC ULTRASOUND SYSTEM | Apr 02, 1992 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K915436 | BLADDERSCAN BVI 2500 | Mar 03, 1992 | Substantially Equivalent | DIAGNOSTIC ULTRASOUND CORP. |
| K913067 | DGH-4000 A-SCAN/PACHYMETER | Jan 31, 1992 | Substantially Equivalent | DGH TECHNOLOGY, INC. |
| K914013 | SIEMENS SI-400 | Dec 02, 1991 | Substantially Equivalent | SIEMENS ULTRASOUND, INC. |
| K911584 | DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 | Oct 24, 1991 | Substantially Equivalent | PIE MEDICAL EQUIPMENT B.V. |
| K911464 | INTERSON DISPOSABLE BIOPSY NEEDLE | Sep 27, 1991 | Substantially Equivalent | INTERSON CORP. |
| K910956 | COMPUSCAN LT BIOMETRIC RULER AND IOL CALCULATOR | Sep 04, 1991 | Substantially Equivalent | STORZ INSTRUMENT CO. |
| K910342 | SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Aug 19, 1991 | Substantially Equivalent | MEDISON CO., LTD. |
| K911200 | SI-1200 / ILUS | Jun 17, 1991 | Substantially Equivalent | SIEMENS ULTRASOUND, INC. |
| K905522 | LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED | Jun 11, 1991 | Substantially Equivalent | LABORATORY EQUIPMENT CORP. |
| K911107 | SONARSCAN 128 ULTRASOUND SCANNER | Jun 10, 1991 | Substantially Equivalent | DIAGNOSTIC SONAR USA |
| K904853 | MODEL STT-100 | May 15, 1991 | Substantially Equivalent | SONOCARE, INC. |
| K904019 | QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM | Mar 22, 1991 | Substantially Equivalent | QUANTUM MEDICAL SYSTEMS, INC. |
| K903603 | ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9) | Feb 26, 1991 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K905294 | EUB-315 | Feb 25, 1991 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K896100 | EUB-565 DIAGNOSTIC ULTRASOUND DEVICE | Jan 24, 1991 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K904692 | DB 3000 A-SCAN SYSTEM | Jan 14, 1991 | Substantially Equivalent | OCUSERV INSTRUMENTS, INC. |
| K903326 | NIDEK US-2000 | Nov 21, 1990 | Substantially Equivalent | NIDEK, INC. |
| K902214 | BIOPSY NEEDLE TRANSPONDER SYSTEM | Nov 08, 1990 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K902411 | NIDEK US-2500 W/BIOMETRY UNIT US-2520 | Oct 09, 1990 | Substantially Equivalent | NIDEK, INC. |
| K902965 | FDI 2000 ULTRASONIC SKIN SCANNER | Sep 26, 1990 | Substantially Equivalent | FULMER DYSON INTL. |
| K900881 | OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM | Sep 25, 1990 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K897042 | EUB-515 DIAGNOSTIC ULTRASOUND DEVICE | Sep 13, 1990 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K901467 | VISION DIAGNOSTIC ULTRASONIC SCANNER | Sep 05, 1990 | Substantially Equivalent | THE PROBE CORP. |
| K900805 | ALOKA 500 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM | Aug 23, 1990 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K901033 | MER MULTIPLANE RECTAL PROBE (MRP) | Aug 22, 1990 | Substantially Equivalent | MEDICAL EQUIPMENT RESOURCES |
| K896356 | AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM | Aug 21, 1990 | Substantially Equivalent | ESAOTE BIOMEDICA SPA |
| K902582 | ALLERGAN HUMPHREY A/B SCAN , MODEL 835 | Aug 14, 1990 | Substantially Equivalent | ALLERGAN HUMPHREY |
| K896999 | SDL 310 DIAGNOSTIC ULTRASOUND INSTRUMENT | Aug 09, 1990 | Substantially Equivalent | SHIMADZU CORP. |
| K902007 | I3SYSTEM-ABD | Jul 20, 1990 | Substantially Equivalent | INNOVATIVE IMAGING, INC. |
| K896480 | SIEMENS SONOLINE AC | Jul 13, 1990 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K900469 | ULTRASOUND SCANNER MODEL #1150 | Jul 09, 1990 | Substantially Equivalent | PIE MEDICAL USA BV |
| K896714 | AUSONICS 5000 | Jun 11, 1990 | Substantially Equivalent | AUSONICS PTY LTD. |
| K896755 | ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM | May 07, 1990 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K884644 | ADDIT. TRANS. EUP-B31/033J/V33/U33/032T/L33/U322 | Apr 13, 1990 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K896173 | ULTRASCAN(R) | Apr 11, 1990 | Substantially Equivalent | TOPICAL DELIVERY SYSTEMS |
| K895645 | BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM | Mar 06, 1990 | Substantially Equivalent | BIOSOUND, INC. |
| K895147 | QUANTUM QAD-1E ANGIODYNOGRAPH ULTRASOUND SYSTEM | Feb 23, 1990 | Substantially Equivalent | QUANTUM INTL. |
| K896150 | IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC | Jan 18, 1990 | Substantially Equivalent | TEKNAR, INC. |
| K896029 | DIGITAL ULTRASOUND IMAGING SYSTEM DUB 20 | Jan 12, 1990 | Substantially Equivalent | G.W.B. INTL., LTD. |
| K895614 | CIVCO LATEX ULTRASOUND SHEATHS | Dec 14, 1989 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K895071 | AI5200 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCER | Oct 12, 1989 | Substantially Equivalent | ACOUSTIC IMAGING |
| K893225 | COUPLANT WARMING DEVICE | Oct 12, 1989 | Substantially Equivalent | ECHO ULTRASOUND |
| K894806 | SIEMENS ENDO-P-PROBE | Oct 05, 1989 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K891449 | SONOLINE CF | Oct 05, 1989 | Substantially Equivalent | SIEMENS ULTRASOUND, INC. |
| K894834 | DERMASCAN C, AN ULTRASONIC DIAGNOSTIC SYSTEM | Oct 02, 1989 | Substantially Equivalent | BRYMILL CORP. |
| K893996 | CUSIS ULTRASOUND SKIN IMAGING SYSTEM | Sep 21, 1989 | Substantially Equivalent | STIEFEL RESEARCH INSTITUTE, INC. |
| K892386 | DIAGNOSTIC ULTRASOUND SYSTEM: MODEL SSA-250A | Sep 12, 1989 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K890913 | SDU 800 DIAGNOSTIC ULTRASOUND INSTRUMENT | Sep 06, 1989 | Substantially Equivalent | SHIMADZU PRECISION INSTRUMENTS, INC. |
| K893837 | CVIS ULTRA-SCAN ONE IMAGING CATHETER | Aug 22, 1989 | Substantially Equivalent | CARDIOVASCULAR IMAGING SYSTEMS, INC. |
| K890275 | ACUSON S328 TRANSDUCER FOR FETAL CARDIAC PULSED | Jul 31, 1989 | Substantially Equivalent | ACUSON CORP. |
| K884271 | ACUSON S328 TRANSDUCER FOR FETAL PULSED DOPPLER | Jul 27, 1989 | Substantially Equivalent | ACUSON CORP. |
| K892355 | M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ | Jul 24, 1989 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K890963 | SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4 | Jul 19, 1989 | Substantially Equivalent | ESAOTE BIOMEDICA ELETTRONICA |
| K893035 | OPHTHASCAN 'S' MINI-A | Jun 12, 1989 | Substantially Equivalent | BIOPHYSIC MEDICAL, INC. |
| K891452 | SPECTRA ULTRASOUND SYSTEM W/COLOR FLOW MODULE | Jun 07, 1989 | Substantially Equivalent | DIASONICS, INC. |
| K891453 | DIAGNOSTIC ULTRASOUND TRANSDUCER: PVE-582V | Jun 01, 1989 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K891225 | OPTIONAL PROBE OF CANON IOL ESTIMATOR KU-1 | May 31, 1989 | Substantially Equivalent | CANON U.S.A., INC. |
| K891386 | CVIS ULTRA-SCAN ONE IMAGING SYSTEM | May 16, 1989 | Substantially Equivalent | CARDIOVASCULAR IMAGING SYSTEMS, INC. |
| K891309 | 5.0 MHZ ARRAY INTRAVAGINAL TRANSDUCER | May 16, 1989 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K890969 | TRANSESOPHAGEAL TRANSDUCER PEF-511SA | May 16, 1989 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K890772 | ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI. | May 10, 1989 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K890519 | LABSONICS MAMM-O-MATE MODEL NO. 918084-1 | May 03, 1989 | Substantially Equivalent | LABORATORY EQUIPMENT CORP. |
| K890173 | INTERSPEC APOGEE | Apr 14, 1989 | Substantially Equivalent | INTERSPEC, INC. |
| K883917 | NATURAL IMAGE ULTRASOUND TRANSMISSION COUPLANT | Mar 31, 1989 | Substantially Equivalent | SONOMED TECHNOLOGY, INC. |
| K885228 | RT6800 ECHOCARDIOGRAPHY SYSTEM | Mar 14, 1989 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K881336 | BRYMASCAN-A | Mar 14, 1989 | Substantially Equivalent | BRYMILL CORP. |
| K883359 | DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A | Jan 25, 1989 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K884632 | ACUSON I5100 ULTRASOUND TRANSDUCER | Jan 13, 1989 | Substantially Equivalent | ACUSON CORP. |
| K884395 | HP 21362B TRANSESOPHAGEAL ULTRASOUND IMAGING TRANS | Jan 10, 1989 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K884299 | APA-C CATALOG NUMBER A-8001-C | Jan 10, 1989 | Substantially Equivalent | AUSONICS PTY LTD. |
| K884595 | OPHTHASCAN MINI-B | Jan 03, 1989 | Substantially Equivalent | BIOPHYSIC MEDICAL, INC. |
| K883925 | UROIMAGER | Dec 15, 1988 | Substantially Equivalent | AUSONICS PTY LTD. |
| K883079 | WWDS-005 HUMAN RECTAL PROBE | Dec 14, 1988 | Substantially Equivalent | AUSONICS PTY LTD. |
| K875187 | SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT | Dec 12, 1988 | Substantially Equivalent | SHIMADZU CORP. |
| K883752 | ACUSON L538 TRANSDUCER | Dec 01, 1988 | Substantially Equivalent | ACUSON CORP. |
| K881140 | ULTRAMARK 4+ ULTRASOUND W/3.5 MHZ 40R CONVEX ARRAY | Nov 29, 1988 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K883481 | HP 77025A/77030A ULTRA. SYSTEM/HP 77020CV UPGRADE | Nov 04, 1988 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K882478 | 100-01778-52 ULTRASOUND SYSTEM | Oct 12, 1988 | Substantially Equivalent | DIASONICS, INC. |
| K883546 | TEEC (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) TRANSDUCER | Oct 07, 1988 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K883965 | PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR | Oct 05, 1988 | Substantially Equivalent | TEKNAR, INC. |
| K881889 | CANON IOL ESTIMATOR KU-1 | Sep 15, 1988 | Substantially Equivalent | CANON U.S.A., INC. |
| K881850 | TEKNAR PERCU-SCAN | Aug 29, 1988 | Substantially Equivalent | TEKNAR, INC. |
| K874854 | GPS/WGPS/PREVIEW GP | Aug 25, 1988 | Substantially Equivalent | LABSONICS, INC. |
| K883238 | GENESIS II TRANSCRANIAL PROBE | Aug 24, 1988 | Substantially Equivalent | BIOSOUND, INC. |
| K881834 | MODEL SSD-870 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Aug 24, 1988 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K882162 | NIDEK US-3000 | Aug 19, 1988 | Substantially Equivalent | NIDEK, INC. |
| K882959 | ENDOVAGINAL PROBE, SMS-510VA | Aug 18, 1988 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K882805 | CILCO VILLASENOR PACHYMETER | Aug 12, 1988 | Substantially Equivalent | COOPERVISION-CILCO |
| K873452 | MODIFIED MODEL SSD-650 SYSTEM | Jul 28, 1988 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K874192 | MULTIPURPOSE TRANSDUCER RANGE | Jul 19, 1988 | Substantially Equivalent | PIE DATA MEDICAL BV |
| K875357 | BIOPSY FIXATION UNIT-TYPE UA 0997 | Jul 01, 1988 | Substantially Equivalent | BRUEL & KJAER INDUSTRI A/S |
| K874211 | EUB-450 DIAGNOSTIC ULTRASOUND DEVICE | Jun 23, 1988 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K881605 | BIOPSY GUIDE | Jun 21, 1988 | Substantially Equivalent | TEKNAR, INC. |
| K874028 | ACUSON S328 TRANSDUCER | Jun 21, 1988 | Substantially Equivalent | ACUSON COMPUTED SONOGRAPHY |
| K880839 | AI 5200 DIAGNOSTIC ULTRASOUND SYSTEM | Jun 10, 1988 | Substantially Equivalent | PHOENIX IMAGING |
| K880580 | EXTENDED MULTIPURPOSE TRANSDUCER RANGE | Jun 08, 1988 | Substantially Equivalent | PIE MEDICAL USA BV |
| K881208 | PROBE SHEATH FOR ADMS ULTRASOUND PROBE | May 16, 1988 | Substantially Equivalent | ADVANCED DIAGNOSTIC MEDICAL SYSTEMS, INC. |
| K875251 | ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE | May 11, 1988 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K874363 | ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI. | May 02, 1988 | Substantially Equivalent | ACUSON COMPUTED SONOGRAPHY |
| K881028 | 7.5 MHZ ENDORECTAL PROBE | Apr 27, 1988 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K874685 | TRANS-SCAN 3-D TRANSCRANIAL DOPPLER | Apr 25, 1988 | Substantially Equivalent | CAROLINA MEDICAL ELECTRONICS |
| K874684 | TC2-64B TRANSCRANIAL DOPPLER | Apr 25, 1988 | Substantially Equivalent | CAROLINA MEDICAL ELECTRONICS |
| K880714 | DIASONICS QT ENDORECTAL 7.5 MHZ PROBE | Apr 21, 1988 | Substantially Equivalent | DIASONICS, INC. |
| K874683 | THE ESI-2000 ULTRASOUND UNIT | Apr 18, 1988 | Substantially Equivalent | ELSCINT, INC. |
| K874548 | SIM 4000C | Apr 18, 1988 | Substantially Equivalent | OTE-BIOMEDICA ELETTRONICA S.P.A |
| K875240 | TRANS/V NEEDLE GUIDE | Apr 15, 1988 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K875236 | TRANS/P NEEDLE GUIDE | Apr 15, 1988 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K875128 | TRANS/R NEEDLE GUIDE | Apr 15, 1988 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K880659 | TEKNAR PROSCAN ACCESSORY PROBE | Apr 14, 1988 | Substantially Equivalent | TEKNAR, INC. |
| K875241 | CIVCO SEED IMPLANT NEEDLE GUIDE | Apr 14, 1988 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K873845 | SIM 4000I | Apr 07, 1988 | Substantially Equivalent | OTE-BIOMEDICA ELETTRONICA S.P.A |
| K880219 | TRANSRECTAL PROBE BD65S-TR | Mar 31, 1988 | Substantially Equivalent | ELSCINT, INC. |
| K873937 | SDR 3500 (PHILIPS PLATINUM +) | Mar 23, 1988 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K880081 | VISION CARE/PHAKOSYSTEMS ECHOPACH | Mar 15, 1988 | Substantially Equivalent | PHAKOSYSTEMS, INC. |
| K880065 | NIDEK UP-2000 | Mar 15, 1988 | Substantially Equivalent | NIDEK, INC. |
| K873159 | COMBISON(R) 310A REAL TIME ULTRASOUND SCANNER | Mar 01, 1988 | Substantially Equivalent | CONE INSTRUMENTS, INC. |
| K872288 | SONOLAYER-V, SAL-38B | Jan 11, 1988 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K871004 | EUB-410 DIAGNOSTIC ULTRASOUND DEVICE | Dec 11, 1987 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K872726 | DGH-3000A A-SCAN | Dec 04, 1987 | Substantially Equivalent | DGH TECHNOLOGY, INC. |
| K873096 | COLOR FLOW IMAGING | Nov 23, 1987 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K871938 | VISION CARE/PHAKOSYSTEMS ECHORULE | Nov 23, 1987 | Substantially Equivalent | PHAKOSYSTEMS, INC. |
| K872307 | VOLUMETRIC PACKAGE STEPPER H4222AA/CALCU. H4222AB | Sep 08, 1987 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K871536 | OPHTHASONIC A-SCAN/ B-SCAN | Aug 26, 1987 | Substantially Equivalent for Some Indications | TEKNAR, INC. |
| K854654 | SM PART SERVO SEC. DUPLEX DOP 7-5/5 9814-219-50007 | Aug 19, 1987 | Substantially Equivalent for Some Indications | PHILIPS MEDICAL SYSTEMS, INC. |
| K872027 | OLYMPUS GF-UM2/EU-M2 | Aug 17, 1987 | Substantially Equivalent | OLYMPUS CORP. |
| K864807 | TEKNAR PROSCAN(TM) | Jul 10, 1987 | Substantially Equivalent | TEKNAR, INC. |
| K870964 | ESI-1002 SYSTEM AND DC100S/C50M-P TRANSDUCER | Mar 13, 1987 | Substantially Equivalent | ELSCINT, INC. |
| K860581 | QAD-1 ANGIODYNOGRAPH ULTRASOUND SYSTEM | Feb 13, 1987 | Substantially Equivalent | QUANTUM MEDICAL SYSTEMS, INC. |
| K864336 | PACHYMETER SYSTEM V | Jan 09, 1987 | Substantially Equivalent | COOPERVISION, INC. |
| K863947 | SONOLAYER-L, SAL-77B | Jan 09, 1987 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K862867 | EUB-310 ULTRASONIC SCANNER | Jan 05, 1987 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K863780 | ADA-1000 (ADVANCED DIGITAL ARRAY) | Dec 29, 1986 | Substantially Equivalent for Some Indications | DIASONICS, INC. |
| K864398 | STORZ SOLID & ANGLED SOLID CONTACT PROBES | Dec 18, 1986 | Substantially Equivalent | STORZ INSTRUMENT CO. |
| K860757 | OPHTHASONIC A-SCAN | Dec 18, 1986 | Substantially Equivalent | TEKNAR, INC. |
| K863576 | EUB-400 DIAGNOSTIC ULTRASOUND DEVICE | Dec 12, 1986 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K862127 | DYMAX PERSONAL SCANNER | Dec 11, 1986 | Substantially Equivalent | DYMAX CORP. |
| K862165 | ELECTRONIC ULTRASOUND SCANNER, MODEL EUB-340 | Nov 28, 1986 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K863338 | 7.5 MHZ LINEAR SMALL PARTS PROBE | Nov 24, 1986 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K863096 | 5.O MHZ SECTOR PROBE, MODEL 8818106 LH 307 | Nov 10, 1986 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K863043 | 3.5 MHZ SECTOR PROBE, MODEL 8818080 LH 305 | Nov 10, 1986 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K863041 | 3.5 MHZ SECTOR PROBE, MODEL 8818098 LH306 | Nov 10, 1986 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K862164 | EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER | Nov 04, 1986 | Substantially Equivalent for Some Indications | HITACHI MEDICAL CORP. OF AMERICA |
| K852502 | AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849 | Oct 23, 1986 | Substantially Equivalent | BRUEL & KJAER INDUSTRI A/S |
| K862151 | COLOR FLOW MAPPING (CFM) OPTION - MODEL 77020 CF | Sep 19, 1986 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K854653 | CILCO SONOMETRICS DIGICON | Sep 04, 1986 | Substantially Equivalent | COOPERVISION, INC. |
| K861538 | 860 COLOR DOPPLER OR COLORVIEW 860 | Aug 25, 1986 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K862166 | SONORANGER | Aug 18, 1986 | Substantially Equivalent | AUSONICS PTY LTD. |
| K860697 | ULTRASOUND IMAGING SYSTEM MODEL 280 SL | Jul 24, 1986 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K862681 | ULTRAMARK 1 ULTRASOUND SYSTEM | Jul 16, 1986 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K860123 | 5.0 MHZ INTRAOPERATIVE ARRAY | Jul 07, 1986 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K861376 | COMBISON R 320A | Jul 03, 1986 | Substantially Equivalent | CONE INSTRUMENTS, INC. |
| K861335 | STORZ COMPUSCAN 68K | Jun 30, 1986 | Substantially Equivalent | STORZ INSTRUMENT CO. |
| K853565 | ARTIS ULTRASOUND IMAGING SYSTEM | Jun 30, 1986 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K860081 | ESI 2000 DIAGNOSTIC ULTRASOUND SYSTEM TRANSDUCERS | Jun 16, 1986 | Substantially Equivalent | ELSCINT, INC. |
| K854959 | LINEAR SCANNER PROBE, MODEL TL-50 | Jun 16, 1986 | Substantially Equivalent | ELSCINT, INC. |
| K854389 | NIDEK US-1600 A-SCAN | Apr 08, 1986 | Substantially Equivalent | NIDEK, INC. |
| K854668 | 5.0 MHZ LINEAR ARRAY SONOLINE PROBE | Mar 20, 1986 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K854667 | 7.5 MHZ LINEAR ARRAY SONOLINE PROBE | Mar 20, 1986 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K853147 | SCANO 731B & 731C ULTRASOUND SOFT TIS DEPT MEAS SY | Mar 13, 1986 | Substantially Equivalent | SCANO, INC. |
| K855124 | CONVEX PROBE, PVE-382M | Mar 12, 1986 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K854555 | GL590 DIAGNOSTIC ULTRASOUND EQUIPMENT | Mar 12, 1986 | Substantially Equivalent | GL ULTRASOUND LTD. |
| K860062 | OCULAB PACHPEN | Mar 10, 1986 | Substantially Equivalent | OCULAB, INC. |
| K860061 | OCULAB BIOMETRICPEN | Mar 10, 1986 | Substantially Equivalent | OCULAB, INC. |
| K852686 | SONOLINE CD | Mar 10, 1986 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K854743 | 2.5 MHZ PHASED ARRAY SECTOR MERIDIAN PROBE | Feb 28, 1986 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K854969 | CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN) | Feb 27, 1986 | Substantially Equivalent | CILCO, INC. |
| K853739 | SONOLAYER SAL-55A/55AS | Feb 24, 1986 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K853702 | ULTRASOUND COUPLANT SHEET/SOLID ULTRASOUND COUPLAN | Feb 13, 1986 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K852862 | CORNEO-GAGE TWO | Jan 30, 1986 | Substantially Equivalent | SONOGAGE, INC. |
| K853946 | SONOLINE LX | Jan 16, 1986 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K844112 | MYOPACH ULTRASONIC PACHOMETER | Jan 16, 1986 | Substantially Equivalent | MYOCURE, INC. |
| K853008 | SONOLINE SL-2(ULTRASOUND SCANNER) | Jan 13, 1986 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K851972 | DIASONICS ADA400 ADVANCED DIGITAL ARRAY | Dec 31, 1985 | Substantially Equivalent | DIASONICS, INC. |
| K853217 | QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES | Dec 30, 1985 | Substantially Equivalent | QUANTUM MEDICAL SYSTEMS, INC. |
| K854135 | HEWLETT PACKARD ULTRASOUND TRANSDUCER 21230A | Dec 23, 1985 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K853311 | LINEAR ARRAY PROBE PLB-310M FOR SAL-32B | Nov 13, 1985 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K853116 | PAXIAL | Oct 31, 1985 | Substantially Equivalent | BIOPHYSIC MEDICAL, INC. |
| K852362 | UROLOGICAL ULTRASOUND DIAGNOSTIC SYS/EQUIP. SSD-52 | Oct 31, 1985 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K851860 | DIASONICS DRF-200 ULTRASOUND IMAGING SYSTEM | Oct 31, 1985 | Substantially Equivalent | DIASONICS, INC. |
| K851446 | UNIVERSAL SERVICE MODULE | Oct 31, 1985 | Substantially Equivalent | DIASONICS, INC. |
| K850834 | SDL-32 ELECTRONIC LINEAR SCANNER | Oct 31, 1985 | Substantially Equivalent | SHIMADZU CORP. |
| K853087 | STORZ SOLID-STANDOFF PACHYMETRY PROBE | Oct 16, 1985 | Substantially Equivalent | STORZ INSTRUMENT CO. |
| K851895 | POLYGEL ULTRASOUND GEL | Sep 27, 1985 | Substantially Equivalent | PARKER LABORATORIES, INC. |
| K852571 | 3.5 MHZ LINEAR ARRAY, MODEL NO. 83, 39, 509 | Sep 19, 1985 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K852570 | 5.0 MHZ LINEAR ARRAY, MODEL 83, 39, 517 | Sep 19, 1985 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K851807 | RT2600(115V)(220/240V) #H4008A & H4008AE | Sep 19, 1985 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K844686 | OPHTHASCAN B | Sep 13, 1985 | Substantially Equivalent | BIOPHYSIC MEDICAL, INC. |
| K844184 | D300 PORT ULTRASOUND LIN SCAN W/3.5 & 5.0 MHZ PROB | Sep 06, 1985 | Substantially Equivalent | D.R.G. |
| K852549 | SONORANGER | Aug 14, 1985 | Substantially Equivalent | AUSONICS PTY LTD. |
| K851982 | KITECKO ULTRASOUND STANDOFF PAD | Aug 14, 1985 | Substantially Equivalent | 3M COMPANY |
| K851696 | AUSONICS 150 | May 22, 1985 | Substantially Equivalent | AUSONICS PTY LTD. |
| K844916 | MODEL 518 & 519 ULTRASONOSCOPE W/DOPPLER | Apr 22, 1985 | Substantially Equivalent | HOFFREL INSTRUMENTS, INC. |
| K850290 | ULTRASOUND GEL | Apr 18, 1985 | Substantially Equivalent | LITTON DATAMEDIX |
| K844299 | CORNEOMAP 4500 | Apr 18, 1985 | Substantially Equivalent | RADIONICS MEDICAL, INC. |
| K843994 | AUSONICS 357 | Apr 18, 1985 | Substantially Equivalent | AUSONICS PTY LTD. |
| K843971 | AUSONICS 150 | Apr 18, 1985 | Substantially Equivalent | AUSONICS PTY LTD. |
| K850478 | PLUS 1 | Apr 15, 1985 | Substantially Equivalent | DYMAX CORP. |
| K844393 | GL ULTRASOUND SECTOR 170 | Apr 10, 1985 | Substantially Equivalent | GL ULTRASOUND LTD. |
| K850580 | DIAGNOSTIC ULTRASOUND SYS MODEL ULS1000 | Apr 03, 1985 | Substantially Equivalent | ELSCINT, INC. |
| K850116 | BETASONIC III | Mar 29, 1985 | Substantially Equivalent | TEKNAR, INC. |
| K843696 | OPHTHALMIC A-SCAN A-2000 SONOME | Feb 26, 1985 | Substantially Equivalent | SONOMED TECHNOLOGY, INC. |
| K843205 | GL ULTRASOUND Z/SL 8300 | Feb 25, 1985 | Substantially Equivalent | GL ULTRASOUND LTD. |
| K844404 | IREX PS, PORTABLE SCANNER AND 118 | Feb 04, 1985 | Substantially Equivalent | IREX CORP. |
| K844477 | STORZ CORNEO-SCAN II CS2000 | Jan 23, 1985 | Substantially Equivalent | STORZ INSTRUMENT CO. |
| K844472 | CIVCO SCAN DRAPE | Jan 23, 1985 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K844449 | HIGH RESOLUTION 5 MHZ LINEAR ARRAY | Jan 23, 1985 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K843891 | DOPSCAN PLUS DS1060 | Jan 09, 1985 | Substantially Equivalent | CAROLINA MEDICAL ELECTRONICS |
| K842757 | ULTRASCAN DIGITAL B | Jan 09, 1985 | Substantially Equivalent | COOPERVISION, INC. |
| K843320 | RT-50 | Dec 27, 1984 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K842900 | PHILIPS SDR 1200 | Dec 13, 1984 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS, INC. |
| K842880 | MECHANICAL SECTOR PROBE 4 MHZ DFM | Dec 10, 1984 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K842777 | AUTOFOCUS DUAL ELEMENT PROBE | Nov 29, 1984 | Substantially Equivalent | TECHNICARE CORP. |
| K842376 | ULTRAMARK 4 ULTRASOUND SYS | Oct 05, 1984 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K842093 | MK 700 ULTRASOUND SYSTEM | Sep 27, 1984 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K842897 | MEDICAL DIAG. ULTRASOUND INSTR. 77065 | Sep 25, 1984 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K843167 | SONIC AID GREEN ULTRASOUND GEL | Sep 19, 1984 | Substantially Equivalent | WPC BRANDS, INC. |
| K842811 | ULTRASYSTEM LINSCAN PROBE | Sep 17, 1984 | Substantially Equivalent | KELLEY DEVELOPMENT CORP. |
| K842127 | AMERICAN MEDICAL OPTICS IMAGING SYS | Sep 07, 1984 | Substantially Equivalent | AMERICAN MEDICAL OPTICS |
| K841817 | TECHNICARE 248 SL & 260SL | Aug 17, 1984 | Substantially Equivalent | TECHNICARE CORP. |
| K842591 | ULTRASOUND PROBE COVERS-STERILE | Jul 23, 1984 | Substantially Equivalent | APPLIED MEDICAL DEVICES, INC. |
| K842153 | ULTRASOUND TRANSMISSION GEL | Jul 18, 1984 | Substantially Equivalent | WPC BRANDS, INC. |
| K841332 | CIVCO/SUPER SCAN | May 09, 1984 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K840540 | TECHNICARE MODEL 330 | May 09, 1984 | Substantially Equivalent | TECHNICARE CORP. |
| K840451 | BIOPSY ATTACHMENT;DYNEX ULTRASOUND- | May 09, 1984 | Substantially Equivalent | ELSCINT, INC. |
| K840139 | IREX 720 SECTOR SCANNER | May 09, 1984 | Substantially Equivalent | IREX CORP. |
| K834284 | ULTRASOUND SCANNER 501 | May 09, 1984 | Substantially Equivalent | IMEX MEDICAL SYSTEMS, INC. |
| K833667 | DIASONICS DLA-100 | May 09, 1984 | Substantially Equivalent | DIASONICS, INC. |
| K833223 | SONEL 3000A | May 09, 1984 | Substantially Equivalent | CGR MEDICAL CORP. |
| K840408 | LINEAR ARRAY TRANSDUCER OR SCANHEAD | Apr 25, 1984 | Substantially Equivalent | ADR ULTRASOUND |
| K840138 | QTA PROCESSOR MODULE | Apr 25, 1984 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K834280 | SDL-30 | Apr 25, 1984 | Substantially Equivalent | SHIMADZU CORP. |
| K840667 | LINEAR SCANNER 640 | Apr 23, 1984 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K834282 | ULTRA IMAGER 2000 | Apr 23, 1984 | Substantially Equivalent | HONEYWELL, INC. |
| K840611 | DSL-150 | Apr 20, 1984 | Substantially Equivalent | SHIMADZU CORP. |
| K834141 | ULTRASOUND SCAN HEAD 3.5 MHZ | Apr 20, 1984 | Substantially Equivalent | ADR ULTRASOUND |
| K834486 | TECHNICARE 280 | Apr 13, 1984 | Substantially Equivalent | TECHNICARE CORP. |
| K833225 | CALIBRE-TENTATIVE TRADENAME | Feb 28, 1984 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K834087 | MODEL XLE | Feb 27, 1984 | Substantially Equivalent | INTERAD SYSTEMS, INC. |
| K834307 | ULTRASOUND SCANNER XL | Feb 21, 1984 | Substantially Equivalent | INTERAD SYSTEMS, INC. |
| K834285 | KC 100 M | Feb 17, 1984 | Substantially Equivalent | ELSCINT, INC. |
| K834277 | MOD 427 | Feb 17, 1984 | Substantially Equivalent | HOFFREL INSTRUMENTS, INC. |
| K834276 | MOD 456 | Feb 17, 1984 | Substantially Equivalent | HOFFREL INSTRUMENTS, INC. |
| K833680 | SIGMA 20 ELECTRONIC SECTOR SCANNER | Feb 17, 1984 | Substantially Equivalent | KONTRON INSTRUMENTS, INC. |
| K833231 | SOUND IMAGER I | Feb 04, 1984 | Substantially Equivalent | SOUND IMAGING, INC. |
| K833222 | SINUSVU 2500 | Nov 28, 1983 | Substantially Equivalent | RADIONICS MEDICAL, INC. |
| K833233 | HOT SHOT | Oct 28, 1983 | Substantially Equivalent | SCHIFF PHOTO MECHANICS |
| K832331 | US-1000 ULTRASONIC IMAGING SYSTEM | Aug 16, 1983 | Substantially Equivalent | NIDEK, INC. |
| K820042 | OCULAR-BIOMETER 4000 | Jul 22, 1982 | Substantially Equivalent | RADIONICS, INC. |
| K813275 | EPCOM EMS SCAN II | Mar 31, 1982 | Substantially Equivalent | EPCOM MEDICAL SYSTEMS, INC. |
| K820365 | MARK 100 & 300 ULTRASOUND SYSTEM | Mar 26, 1982 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K820364 | MARK 500 ULTRASOUOND SYSTEM | Mar 26, 1982 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K813596 | AUTO SECTOR MCU | Mar 25, 1982 | Substantially Equivalent | TECHNICARE CORP. |
| K820124 | INTEGRAL SECTOR MODULE | Mar 05, 1982 | Substantially Equivalent | SIEMENS GAMMASONICS, INC. |
| K813177 | US ALOKA SSD-256 ULTRASONIC SCANNER | Mar 05, 1982 | Substantially Equivalent | U. S. A. IMAGING CORP. |
| K812686 | SINUSCOPE | Mar 05, 1982 | Substantially Equivalent | JEDMED INSTRUMENT CO. |
| K813397 | SSD-240 ULTRASONIC SCANNER | Mar 02, 1982 | Substantially Equivalent | U. S. A. IMAGING CORP. |
| K813398 | SSD-203 ULTRASONIC SCANNER | Mar 01, 1982 | Substantially Equivalent | U. S. A. IMAGING CORP. |
| K813543 | ADR ULTRASOUND MODELS 4000S & 4000S/L | Feb 24, 1982 | Substantially Equivalent | ADR ULTRASOUND |
| K812435 | DATAPASS | Jan 28, 1982 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K811842 | IMAGER 2000 REAL TIME SYSTEM | Nov 20, 1981 | Substantially Equivalent | SIEMENS GAMMASONICS, INC. |
| K812743 | FETAL VITABILITY TM MODE | Nov 16, 1981 | Substantially Equivalent | TECHNICARE CORP. |
| K812398 | LINUS | Nov 10, 1981 | Substantially Equivalent | FISCHER IMAGING CORP. |
| K812588 | SCANNER 700 | Oct 19, 1981 | Substantially Equivalent | NATIONAL ULTRASOUND CORP. |
| K812014 | DYNEX-44 DIAGNOSTIC ULTRASOUND IMAGING | Sep 16, 1981 | Substantially Equivalent | ELSCINT, INC. |
| K812236 | GOLD(AU 195) GAMMA CAMERA CHECK(FLOOD) | Sep 09, 1981 | Substantially Equivalent | AMERSHAM CORP. |
| K810660 | KREMER CORNEOMETER ULTRASONIC PACHOMETER | Aug 21, 1981 | Substantially Equivalent | ACCUTOME, INC. |
| K811931 | NEEDLE GUIDE ATTACHMENT | Aug 18, 1981 | Substantially Equivalent | TECHNICARE CORP. |
| K811426 | ARTICULATED ARM B-SCANNER | Aug 18, 1981 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K811572 | ATL'S MARK 100/300 ULTRASOUND SYSTEMS | Aug 10, 1981 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K811252 | MS-50 ULTRASONIC IMAGER | Aug 07, 1981 | Substantially Equivalent | KONTRON INSTRUMENTS, INC. |
| K811633 | CIRAS ULTRASONIC SCANNING SYSTEM | Jul 10, 1981 | Substantially Equivalent | AUSONICS PTY LTD. |
| K811316 | TRISCAN, MODELS 38,40,41,43 & 45 | Jul 02, 1981 | Substantially Equivalent | VISIDYNE CORP. |
| K810945 | SCANEL 100 | May 08, 1981 | Substantially Equivalent | CGR MEDICAL CORP. |
| K810914 | 5CM SMALL PARTS SCANNER | May 08, 1981 | Substantially Equivalent | SMITH KLINE DIAGNOSTICS, INC. |
| K802635 | OPHTHALMO ECHOGRAPH MODEL ZD255G | Apr 23, 1981 | Substantially Equivalent | JEDMED INSTRUMENT CO. |
| K810038 | DIGITAL DIAGNOSTIC ULTRASOUND DEVICE | Apr 17, 1981 | Substantially Equivalent | ROHE SCIENTIFIC CORP. |
| K810073 | MARK 500 SYSTEM | Mar 05, 1981 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K802434 | VARIAN V3500 PHASED ARRAY ULTRASONOGRAPH | Feb 19, 1981 | Substantially Equivalent | VARIAN ASSOC., INC. |
| K803157 | AUTO-MATE CAMERA | Feb 02, 1981 | Substantially Equivalent | APTEK LTD. |
| K802905 | MULTI-IMAGE CAMERA-#627 TLC | Jan 15, 1981 | Substantially Equivalent | DUNN SYSTEMS, INC. |
| K802437 | MARK III ULTRASONIC SCANNING SYSTEM | Jan 15, 1981 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K802759 | SIEMENS PHO/SONIC ALPHA 1000 | Jan 07, 1981 | Substantially Equivalent | SIEMENS GAMMASONICS, INC. |
| K802708 | SYSTEM, ECHO, PULSED ULTRASONIC DIAG. | Jan 07, 1981 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K802695 | DATASON RTL II | Jan 07, 1981 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K802532 | PFIZONIC 300 ULTRASOUND SCANNER | Dec 18, 1980 | Substantially Equivalent | PFIZER MEDICAL SYSTEMS, INC. |
| K802531 | PFIZONIC 200 ULTRASOUND SCANNER | Dec 18, 1980 | Substantially Equivalent | PFIZER MEDICAL SYSTEMS, INC. |
| K802530 | PFIZONIC 250 ULTRASOUND SCANNER | Dec 18, 1980 | Substantially Equivalent | PFIZER MEDICAL SYSTEMS, INC. |
| K802528 | PFIZONIC 150 ULTRASOUND SCANNER | Dec 18, 1980 | Substantially Equivalent | PFIZER MEDICAL SYSTEMS, INC. |
| K801954 | HP MODEL 77020A ULTRASOUND SYSTEM | Dec 16, 1980 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K802704 | SIAM 80-INSTANTANEOUS SONOGRAPH W/STOR. | Dec 11, 1980 | Substantially Equivalent | CGR MEDICAL CORP. |
| K802341 | DIOSCAN | Dec 10, 1980 | Substantially Equivalent | SONOMETRICS SYSTEMS, INC. |
| K801986 | DATASON DB SYSTEM | Nov 12, 1980 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K802263 | MINIVISOR TERMINAL | Oct 31, 1980 | Substantially Equivalent | ORGANON TEKNIKA CORP. |
| K802146 | AQUASONIC 100 ULTRASOUND TRANS. GEL, | Oct 10, 1980 | Substantially Equivalent | PARKER LABORATORIES, INC. |
| K801844 | SONIA-SO NOGRAPH-NUMERICAL ANALYSIS | Oct 03, 1980 | Substantially Equivalent | CGR MEDICAL CORP. |
| K801454 | DATASON RTL | Sep 16, 1980 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K801598 | MARK V DUPLEX ULTRASONIC SCANNING SYSTEM | Aug 20, 1980 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K801406 | MARK III ULTRASONIC SCANNING SYSTEM | Jul 28, 1980 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K801060 | HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE | Jun 04, 1980 | Substantially Equivalent | SMITH KLINE DIAGNOSTICS, INC. |
| K801056 | EDP 1200 ULTRASONIC B-SCANNER | Jun 04, 1980 | Substantially Equivalent | TECHNICARE CORP. |
| K800824 | MODEL SKI-200 ABDOMINAL SCANNER | May 14, 1980 | Substantially Equivalent | SMITH KLINE DIAGNOSTICS, INC. |
| K800652 | MODEL E03 ECHO-OPTHALMOSCOPE | May 14, 1980 | Substantially Equivalent | KT MEDICAL, INC. |
| K800101 | 4200 ME ECHOENCEPHALOGRAPH | May 02, 1980 | Substantially Equivalent | KT MEDICAL, INC. |
| K800532 | S.K. DIAG. ULTRASOUND BODY SCANNER | Apr 10, 1980 | Substantially Equivalent | SMITH KLINE DIAGNOSTICS, INC. |
| K800531 | S.K. DIAG. ULTRASND. SMALL PARTS SCAN | Apr 10, 1980 | Substantially Equivalent | SMITH KLINE DIAGNOSTICS, INC. |
| K800434 | PORTABLE MEDICAL ULTRASOUND SCANNER | Apr 10, 1980 | Substantially Equivalent | BION ENT., LTD. |
| K800100 | 7200 MA ECHO-OPHTHALMOSCOPE | Feb 21, 1980 | Substantially Equivalent | KT MEDICAL, INC. |
| K800099 | INTRACULA II | Feb 21, 1980 | Substantially Equivalent | KT MEDICAL, INC. |
| K791766 | ECHO-OCULOMETER #3000 | Feb 19, 1980 | Substantially Equivalent | JEDMED INSTRUMENT CO. |
| K800139 | SEARLE PHO/SONIC ALPHA 2000 | Feb 11, 1980 | Substantially Equivalent | G.D. SEARLE AND CO. |
| K800094 | COMBISON 200 & COMBISON 202 | Feb 11, 1980 | Substantially Equivalent | KT MEDICAL, INC. |
| K800091 | COMBISON 100-MODEL 100 & 110 | Feb 11, 1980 | Substantially Equivalent | KT MEDICAL, INC. |
| K792492 | UCA GEL | Feb 05, 1980 | Substantially Equivalent | VANARAY LABORATORIES, INC. |
| K792489 | UCA CREAM | Feb 05, 1980 | Substantially Equivalent | VANARAY LABORATORIES, INC. |
| K792638 | HIGH RESOLUTION IMAGING SYSTEM | Jan 28, 1980 | Substantially Equivalent | UNIRAD CORP. |
| K792585 | SMV 120 SONIC MAMMOGRAPHIC VIEWER | Jan 21, 1980 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K792446 | ADR REAL-TIME SECTOR SCANNER | Jan 09, 1980 | Substantially Equivalent | ADR ULTRASOUND |
| K792388 | OCTOSON | Dec 20, 1979 | Substantially Equivalent | AUSONICS PTY LTD. |
| K791775 | VARIAN V-3300, PHASED ARRAY ULTRASON | Oct 26, 1979 | Substantially Equivalent | VARIAN ASSOC., INC. |
| K791755 | DATASON-GS | Oct 26, 1979 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K791744 | VARIAN V-3400, PHASED ARRAY ULTRASON | Oct 26, 1979 | Substantially Equivalent | VARIAN ASSOC., INC. |
| K791040 | SECTOR SCANNER, SDU-100, COMPUTERIZED | Oct 04, 1979 | Substantially Equivalent | SHIMADZU CORP. |
| K791298 | DIAGNOSTIC ULTRASOUND SYSTEM | Sep 27, 1979 | Substantially Equivalent | XONICS MEDICAL SYSTEMS, INC. |
| K791429 | EMISONIC 4290 | Sep 21, 1979 | Substantially Equivalent | EMI MEDICAL, INC. |
| K791505 | ROHNAR 7000 DIGITAL DIAGN ULTRASOUND | Sep 17, 1979 | Substantially Equivalent | ROCHE SCIENTIFIC CORP. |
| K791344 | MODEL 1350 GRAPHICS TRANSLATOR | Sep 17, 1979 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K791343 | MODEL 1338A CRT DISPLAY | Sep 17, 1979 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K790694 | BRITT LENS COMPUTER | Aug 10, 1979 | Substantially Equivalent | BRITT CORP., INC. |
| K790321 | DATASON DB | Aug 01, 1979 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K790489 | MICROVIEW | Apr 23, 1979 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K790396 | ULTRASONIC DIAGNOSTIC SYSTEM | Mar 21, 1979 | Substantially Equivalent | HOFFREL INSTRUMENTS, INC. |
| K790285 | IMAGER, PHO/SONIC SERIES 2000 | Mar 08, 1979 | Substantially Equivalent | G.D. SEARLE AND CO. |
| K790023 | OCCULAR COMPU-SCAN | Feb 12, 1979 | Substantially Equivalent | STORZ INSTRUMENT CO. |
| K790037 | SONO TRAK T.M. | Jan 26, 1979 | Substantially Equivalent | NARCO AIR-SHIELDS |
| K782158 | SCANNER-SV | Jan 25, 1979 | Substantially Equivalent | HRL, INC. |
| K781177 | ULTRASOUND BREAST SCANNING DEVICE | Jan 03, 1979 | Substantially Equivalent | LIFE INSTRUMENT CORP. |
| K782060 | MULTIFORMAT FILM CASSETTE TRANSPORT | Dec 20, 1978 | Substantially Equivalent | MEDISCAN, INC. |
| K781709 | SCANNER, LINEAR | Oct 24, 1978 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
| K781508 | WATERPATH SCANNING OPTION | Sep 26, 1978 | Substantially Equivalent | G.D. SEARLE AND CO. |
| K781344 | OPTION PHO/SONIC B-MODE SCANNER | Aug 21, 1978 | Substantially Equivalent | G.D. SEARLE AND CO. |
| K781079 | SONOGRAF ULTRASOUND B-SCANNING SYSTEM | Jul 17, 1978 | Substantially Equivalent | OHIO NUCLEAR, INC. |
| K781051 | EMISONIC 4201 | Jul 17, 1978 | Substantially Equivalent | EMI MEDICAL, INC. |
| K780578 | SONOGRAF EDP REAL-TIME ADAPTER | May 25, 1978 | Substantially Equivalent | FOLEY, LARDNER, HOLLABAUGH & JACOBS |
| K770999 | LITTON 300L ULTRASOUND SYSTEM | Jan 12, 1978 | Substantially Equivalent | ELECTRA-PHYSICS LABORATORIES, INC. |
| K772012 | VIDEO ADAPTER FOR GRAPHIC RECORDERS | Nov 07, 1977 | Substantially Equivalent | HONEYWELL, INC. |
| K771930 | EMISONIC 4500 TM | Oct 27, 1977 | Substantially Equivalent | EMI MEDICAL, INC. |
| K771934 | LINEAR ARRAY B-MODE SCANNER | Oct 25, 1977 | Substantially Equivalent | G.D. SEARLE AND CO. |
| K771688 | ECHO-OCULOMETER | Sep 26, 1977 | Substantially Equivalent | STORZ INSTRUMENT CO. |
| K771600 | ULTRASOUND | Sep 22, 1977 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K771291 | IMAGE SCANNING TYPE SONOLAY. SAL-10A | Aug 16, 1977 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K771290 | CONTACT COMPOUNT SONOLAY. SAC-10A | Aug 03, 1977 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
FEI Numbers
This FDA classification entry is associated with 345 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 346 registration numbers. Click on an entry to view related FDA registrations.