Product Code: ITX
FDA class 2
21 CFR 892.1570
Transducer, Ultrasonic, Diagnostic
Radiology
A diagnostic ultrasonic transducer is a device that converts electrical energy into ultrasonic waves and receives returning echoes to generate diagnostic images of internal body structures, used with ultrasound imaging systems across a wide range of clinical applications. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is ITX, regulated under 21 CFR 892.1570, within the Radiology medical specialty. This device is eligible for third party 510(k) review.
510(k)s
408
FEI Numbers
388
Registration Numbers
389
Unique Applicants
185
Years Active
47
Basic Information
- Product Code
- ITX
- Device Class
- FDA class 2
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 408 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250762 | ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R) | Jul 11, 2025 | Substantially Equivalent | Olympus Medical Systems Corporation |
| K250524 | Mendaera Guidance System | Jul 02, 2025 | Substantially Equivalent | Mendaera, Inc. |
| K250469 | Accuro® 3S Needle Guide Kit | Jun 13, 2025 | Substantially Equivalent | Rivanna Medical, Inc. |
| K241662 | Ultrasound Transducer Cover | Aug 30, 2024 | Substantially Equivalent | Vitrolife Sweden AB |
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15) | Aug 15, 2024 | Substantially Equivalent | Parker Laboratories, Inc. |
| K241615 | Transducer Probe Cover | Jul 03, 2024 | Substantially Equivalent | Hony Medical Co., Ltd. |
| K233109 | TP Pivot Pro Needle Guide | Dec 22, 2023 | Substantially Equivalent | CIVCO Medical Solutions |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | Dec 13, 2023 | Substantially Equivalent | Fujifilm Healthcare Americas Corporation |
| K231783 | VitroPRO | Nov 14, 2023 | Substantially Equivalent | CIVCO Medical Instruments Co., Inc. |
| K223689 | Disposable Needle Guides and Grids | Aug 02, 2023 | Substantially Equivalent | Advance Medical Designs, Inc. |
| K222460 | Intraoperative Ultrasound Probe Cover | May 12, 2023 | Substantially Equivalent | Exact Medical Manufacturing |
| K221278 | Transducer Probe Cover | Jan 11, 2023 | Substantially Equivalent | Hony Medical Co., Ltd. |
| K222052 | VitroPRO | Nov 22, 2022 | Substantially Equivalent | CIVCO Medical Instruments Co., Inc. |
| K213087 | Natural Rubber Latex Ultrasound Transducer Probe Covers | Jun 07, 2022 | Substantially Equivalent | Global Protection Corp. |
| K211270 | CIV-Clear cover | Sep 13, 2021 | Substantially Equivalent | CIVCO Medical Instruments Co., Inc. |
| K211969 | EMM Ultrasonic Transducer Cover | Aug 13, 2021 | Substantially Equivalent | Exact Medical Manufacturing |
| K201425 | Disposable Intraoperative Probe (DIOP8) | Feb 19, 2021 | Substantially Equivalent | Huntleigh Healthcare Limited |
| K202035 | Vscan Air | Nov 20, 2020 | Substantially Equivalent | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| K191491 | EZ-Cover | Jun 05, 2020 | Substantially Equivalent | MedXPress.Pro |
| K200733 | Opticross 35 15 MHz Peripheral Imaging Catheter | Apr 17, 2020 | Substantially Equivalent | Boston Scientific Corporation |
| K190802 | Envision ultrasound pad and cover | May 24, 2019 | Substantially Equivalent | CIVCO Medical Solutions |
| K171272 | Cook-Swartz Doppler Flow Probe | Jul 17, 2018 | Substantially Equivalent | Cook Incorporated |
| K180970 | Disposable guides KDNG00 | Jul 10, 2018 | Substantially Equivalent | Koelis |
| K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range | Jul 31, 2017 | Substantially Equivalent | Koelis |
| K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor | Jun 09, 2017 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K170741 | GTK Disposable Needle Guides | Jun 01, 2017 | Substantially Equivalent | GEOTEK Medikal Ltd Sti |
| K171348 | Pinpoint GT Needle Guide Kits | May 22, 2017 | Substantially Equivalent | C.R. Bard, Inc. |
| K170338 | A-View | May 16, 2017 | Substantially Equivalent | Stroke2Prevent B.V. |
| K163502 | iSR'obot Biopsy Kit | May 16, 2017 | Substantially Equivalent | Biobot Surgical Pte Ltd |
| K152126 | UST-5550-R; UST-5536-R; L43K | Aug 17, 2016 | Substantially Equivalent | HITACHI ALOKA MEDICAL AMERICA, INC. |
| K160806 | Verza Guidance System | Aug 05, 2016 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K160414 | Precision Point Biopsy Needle Guide | Aug 01, 2016 | Substantially Equivalent | Corbin Clinical Resources, LLC |
| K153212 | Sheathes Ultrasound Probe Covers | Mar 04, 2016 | Substantially Equivalent | Sheathing Technologies, Inc. |
| K152403 | Permanent Sled Bag | Sep 22, 2015 | Substantially Equivalent | BOSTON SCIENTIFIC |
| K142618 | Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System, ARIETTA 70 Diagnostic Ultrasound System | Oct 16, 2014 | Substantially Equivalent | Hitachi Aloka Medical America, Inc. |
| K141334 | REUSABLE GUIDE | Jul 11, 2014 | Substantially Equivalent | KOELIS |
| K140854 | INTRA-OPERATIVE ULTRASOUND TRANSDUCER | Jun 11, 2014 | Substantially Equivalent | HITACHI ALOKA MEDICAL, LTD. |
| K141093 | 6VT-D ULTRASOUND TRANSDUCER | May 15, 2014 | Substantially Equivalent | GE VINGMED ULTRASOUND AS |
| K131161 | EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, | Sep 17, 2013 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K131528 | NON-PYROGENIC ULTRASOUND TRANSDUCER COVER | Jun 11, 2013 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K123424 | MDU5 PLUS STERILE BAG | Feb 20, 2013 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K122921 | C1-6-D ULTRASOUND TRANSDUCER | Oct 05, 2012 | Substantially Equivalent | GE HEALTHCARE |
| K122515 | C2-9-D ULTRASOUND TRANSDUCER | Sep 11, 2012 | Substantially Equivalent | GE HEALTHCARE |
| K121062 | VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM | Aug 17, 2012 | Substantially Equivalent | GE MEDICAL SYSTEM ISRAEL LTD. |
| K121807 | V5MS TRANSDUCER | Jul 10, 2012 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K113832 | SONICEYE ULTRASOUND TRANSDUCER | Mar 06, 2012 | Substantially Equivalent | BLACKTOE MEDICAL III, INC. |
| K111426 | EUCLID (TM) TIER 1-GW ACCESS SYSTEM | Mar 01, 2012 | Substantially Equivalent | HOUSTON MEDICAL ROBOTICS |
| K120156 | PUREIMAGE ULTRASOUND TRANSMISSION GEL | Feb 08, 2012 | Substantially Equivalent | MEDLINE |
| K110752 | HIGHLAND INSTRUMENTS CES AND TUS INSTRUMENT HOLDER | Jun 28, 2011 | Substantially Equivalent | HIGHLAND INSTRUMENTS |
| K101952 | KONIX ULTRASOUND GEL | May 27, 2011 | Substantially Equivalent | TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA |
| K111021 | CUBESCAN / BIOCON-700 | Apr 27, 2011 | Substantially Equivalent | MCUBE TECHNOLOGY CO., LTD. |
| K110999 | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Apr 26, 2011 | Substantially Equivalent | EDAN INSTRUMENTS, INC. |
| K110920 | UF-760AG | Apr 08, 2011 | Substantially Equivalent | FUKUDA DENSHI CO., LTD. |
| K110202 | FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB | Feb 08, 2011 | Substantially Equivalent | FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| K103629 | PET-512MC TRANSESOPHAGEAL TRANSDUCER | Feb 02, 2011 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K110020 | TERASON T3200 ULTRASOUND SYSTEM | Jan 20, 2011 | Substantially Equivalent | TERATECH CORP. |
| K103645 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM | Jan 12, 2011 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN |
| K103722 | THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM | Jan 05, 2011 | Substantially Equivalent | MEDISON CO., LTD. |
| K102865 | DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM | Nov 03, 2010 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K102041 | AIXPLORER | Oct 13, 2010 | Substantially Equivalent | SUPERSONIC IMAGINE |
| K101816 | STN PROBE | Aug 19, 2010 | Substantially Equivalent | SUMMIT DOPPLER SYSTEMS, INC. |
| K101757 | SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM, SONOSITE MAXX SERIES ULTRASOUND SYSTEM | Aug 12, 2010 | Substantially Equivalent | SONOSITE,INC. |
| K101829 | THE SONOACE R3 DIAGNOSTIC ULTRASOUND SYSTEM | Jul 16, 2010 | Substantially Equivalent | MEDISON CO., LTD. |
| K101008 | DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY | Jun 08, 2010 | Substantially Equivalent | SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
| K101041 | DC-7 DIAGNOSTIC ULTRASOUND SYSTEM | Apr 30, 2010 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K100204 | SONALIS | Feb 19, 2010 | Substantially Equivalent | SMITH ASSOCIATES |
| K100067 | MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM | Jan 28, 2010 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K093713 | ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM | Jan 19, 2010 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS |
| K093714 | SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 10, 2009 | Substantially Equivalent | MEDISON CO., LTD. |
| K093462 | SONIX ULTRASOUND SCANNER | Nov 20, 2009 | Substantially Equivalent | UltraSonix Medical Corporation |
| K092858 | SAFERSONIC SONOGRAPHY COVER | Nov 10, 2009 | Substantially Equivalent | SAFERSONIC MEDIZINPRODUKTE GMBH |
| K092691 | DC-7 DIAGNOSTIC ULTRASOUND SYSTEM | Oct 15, 2009 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K092756 | GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM | Sep 28, 2009 | Substantially Equivalent | GE VINGMED ULTRASOUND AS |
| K091828 | SHEATHESISO ULTRASOUND TRANSDUCER COVER | Sep 28, 2009 | Substantially Equivalent | SHEATHING TECHNOLOGIES, INC. |
| K092637 | PACSCAN PLUS, MODELS 300P AND 300AP | Sep 24, 2009 | Substantially Equivalent | SONOMED, INC. |
| K091877 | CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL | Sep 02, 2009 | Substantially Equivalent | CHISON MEDICAL IMAGING CO., LTD. |
| K091804 | CX50 VERSION 2.0 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS | Jul 17, 2009 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K091941 | DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM | Jul 09, 2009 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K091680 | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Jun 19, 2009 | Substantially Equivalent | EDAN INSTRUMENTS, INC. |
| K091295 | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 | May 15, 2009 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K090912 | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900 | Apr 15, 2009 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K090465 | DIGDOP ULTRASOUND SYSTEM | Apr 08, 2009 | Substantially Equivalent | THE NEWMAN GROUP, LLC |
| K083824 | HUMANSCAN M5S-D ULTRASOUND TRANSDUCER | Feb 10, 2009 | Substantially Equivalent | HUMANSCAN COMPANY, LTD. |
| K083667 | NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 | Feb 02, 2009 | Substantially Equivalent | B-K MEDICAL APS |
| K083877 | FLYING DIAGNOSTIC ULTRASOUND SYSTEM | Jan 13, 2009 | Substantially Equivalent | NEUSOFT MEDICAL SYSTEMS CO., LTD. |
| K082224 | DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC | Dec 15, 2008 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K082893 | PRAGER SHELL | Dec 05, 2008 | Substantially Equivalent | ESI, INC. |
| K081919 | UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM | Sep 09, 2008 | Substantially Equivalent | FUKUDA DENSHI CO., LTD. |
| K081802 | CX50 DIAGNOSTIC ULTRASOUND SYSTEM | Jul 11, 2008 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K080970 | USHIFU STEPPER | Jun 11, 2008 | Substantially Equivalent | USHIFU DEVELOPMENT COMPANY, LLC |
| K080555 | SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) | Jun 03, 2008 | Substantially Equivalent | IVU IMAGING CORPORATION |
| K073623 | ATLANTIS 018 PERIPHERAL IMAGING CATHETER | Mar 13, 2008 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K080272 | ATLANTIS PVIMAGING CATHETER, MODEL H749364560 | Mar 11, 2008 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K080119 | CLEARSCAN | Feb 21, 2008 | Substantially Equivalent | ESI, INC. |
| K071291 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 | Jan 09, 2008 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K071289 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO | Jan 09, 2008 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K071287 | ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO | Jan 09, 2008 | Substantially Equivalent | SHIMADZU MEDICAL SYSTEMS |
| K072786 | ACUSON S2000 ULTRASOUND SYSTEM | Nov 13, 2007 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K072918 | MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00 | Oct 29, 2007 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS CORPORATION |
| K072826 | APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM | Oct 24, 2007 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K070195 | BROADSOUND, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42B | Oct 15, 2007 | Substantially Equivalent | BROADSOUND CORPORATION |
| K072541 | SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM | Sep 25, 2007 | Substantially Equivalent | SENORX, INC. |
| K072164 | DC-6 DIAGNOSTIC ULTRASOUND SYSTEM | Sep 05, 2007 | Substantially Equivalent | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
| K072285 | ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM | Aug 30, 2007 | Substantially Equivalent | ALOKA CO., LTD. |
| K072266 | ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM | Aug 29, 2007 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K070515 | A-VIEW BASIC AND PLUS | Jul 30, 2007 | Substantially Equivalent | CORDATEC N.V. |
| K070903 | MYLAB40 | Jul 02, 2007 | Substantially Equivalent | ESAOTE EUROPE B.V. |
| K061153 | GYNESONICS EC6 TRANSDUCER | Oct 27, 2006 | Substantially Equivalent | GYNESONICS, INC. |
| K061560 | SONOMARK | Aug 18, 2006 | Substantially Equivalent | MEDICAL PRODUCTS MANUFACTURING, INC. |
| K060947 | SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020 | Apr 19, 2006 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K060879 | MODEL EC9-4 TRANSDUCER | Apr 19, 2006 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K053463 | AIM ACCURACY IN MARKING SYSTEM | Mar 07, 2006 | Substantially Equivalent | GEORGENE AUSTRIA |
| K052517 | SITE-RITE 5 ULTRASOUND SYSTEM | Sep 29, 2005 | Substantially Equivalent | C.R. BARD, INC. |
| K052021 | V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER | Aug 17, 2005 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K050320 | FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT | Aug 15, 2005 | Substantially Equivalent | ASCENDIA MEDTECH AB |
| K050724 | SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM | Apr 18, 2005 | Substantially Equivalent | C.R. BARD, INC. |
| K043425 | SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) | Feb 28, 2005 | Substantially Equivalent | SHEATHING TECHNOLOGIES, INC. |
| K043278 | TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES | Dec 13, 2004 | Substantially Equivalent | TERATECH CORP. |
| K032315 | IOP8 INTRA OPERATIVE PROBE | Nov 18, 2004 | Substantially Equivalent | HUNTLEIGH HEALTHCARE, INC. |
| K041818 | SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020 | Nov 10, 2004 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K042445 | SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT | Oct 19, 2004 | Substantially Equivalent | BARD ACCESS SYSTEMS, INC. |
| K040213 | MHLX7EC TRANSDUCER | Sep 22, 2004 | Substantially Equivalent | MICROHELIX, INC. |
| K041638 | TARGETSCAN BIOPSY KIT | Sep 02, 2004 | Unknown | ENVISIONEERING, LLC. |
| K041637 | TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM | Sep 01, 2004 | Substantially Equivalent | ENVISIONEERING, LLC. |
| K041397 | EG-3830UT | Jun 09, 2004 | Substantially Equivalent | PENTAX PRECISION INSTRUMENT CORP. |
| K041396 | FG-36UX FIBER ULTRASOUND GASTROSCOPE | Jun 09, 2004 | Substantially Equivalent | PENTAX PRECISION INSTRUMENT CORP. |
| K041395 | EG-3630UR | Jun 09, 2004 | Substantially Equivalent | PENTAX PRECISION INSTRUMENT CORP. |
| K040840 | TERATECH MODEL 10V5 SMART PROBE | Apr 14, 2004 | Substantially Equivalent | TERATECH CORP. |
| K022156 | LATEX ULTRASONIC PROBE COVER | Sep 11, 2003 | Substantially Equivalent | PLEASURE LATEX PRODUCTS SDN. BHD. |
| K031920 | CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 | Jul 23, 2003 | Substantially Equivalent | TRANS VASCULAR INCORPORATED |
| K030518 | AMERITEK SURE-POINT TRACKER SYSTEM | May 20, 2003 | Substantially Equivalent | AMERTEK MEDICAL, INC. |
| K031358 | TRANSVAGINAL DOPPLER PROBE | May 09, 2003 | Substantially Equivalent | VASCULAR CONTROL SYSTEMS, INC |
| K030064 | ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY | Jan 22, 2003 | Substantially Equivalent | SONOSITE,INC. |
| K022860 | ATLANTIS PV IMAGING CATHETER, MODEL 36456 | Nov 21, 2002 | Substantially Equivalent | BOSTON SCIENTIFIC, TARGET |
| K023024 | TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02 | Sep 26, 2002 | Substantially Equivalent | VASCULAR CONTROL SYSTEMS, INC |
| K022649 | COOK-SWARTZ DOPPLER FLOW PROBE | Sep 06, 2002 | Substantially Equivalent | COOK VASCULAR, INC. |
| K013363 | CROSSPOINT TRANSACCESS CATHETER | Apr 02, 2002 | Substantially Equivalent | TRANS VASCULAR INCORPORATED |
| K013723 | MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER | Feb 06, 2002 | Substantially Equivalent | HITACHI MEDICAL CORP. |
| K014182 | TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS | Jan 03, 2002 | Substantially Equivalent | TETRAD CORP. |
| K013721 | SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER | Dec 28, 2001 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K002958 | SHAPEABLE DOPPLER FLOW PROBE | Dec 18, 2001 | Substantially Equivalent | COOK VASCULAR, INC. |
| K013849 | TETRAD MODEL TC-EC7-ACP, -L5-, -L7-, -V4-ACP TRANSDUCERS | Dec 03, 2001 | Substantially Equivalent | TETRAD CORP. |
| K013170 | SCANTAC MEMBRANE OR SCANTAC STRIP | Nov 13, 2001 | Substantially Equivalent | SONOTECH, INC. |
| K011265 | ULTRASOUND TRANSDUCER COVER | Oct 30, 2001 | Substantially Equivalent | ADVANCE MEDICAL DESIGNS, INC. |
| K012522 | WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL | Oct 18, 2001 | Substantially Equivalent | NATIONAL THERAPY PRODUCTS INC. |
| K011581 | AMERITEK BRACHYTHERAPY TEMPLATE | Jul 17, 2001 | Substantially Equivalent | AMERTEK MEDICAL, INC. |
| K011284 | THIN FILM DRESSING FOR ULTRASOUND EXAM | Jun 20, 2001 | Substantially Equivalent | MARTIN E. WENDELKEN |
| K011314 | OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM | May 15, 2001 | Substantially Equivalent | ALOKA CO., LTD. |
| K002193 | TETRAD TC-C3-ACP | May 04, 2001 | Substantially Equivalent | TETRAD CORP. |
| K010883 | TERATECH MODEL 8EC4 ENDOCAVITY SMART PROBE | Apr 06, 2001 | Substantially Equivalent | TERATECH CORP. |
| K002856 | AT3C70 TRANSDUCER | Apr 02, 2001 | Substantially Equivalent | SONORA MEDICAL SYSTEMS |
| K002784 | ALOKA UST-5280-5 | Sep 20, 2000 | Substantially Equivalent | ALOKA CO., LTD. |
| K994103 | OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT | Sep 05, 2000 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K994106 | OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE | Jun 02, 2000 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K994069 | OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE | Jun 02, 2000 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K001203 | OLYMPUS UM 2R/3R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR FEMALE REPRODUCTIVE TRACT | May 26, 2000 | Substantially Equivalent | THE OLYMPUS OPTICAL CO. |
| K992178 | BALLOON FOR ULTRASONIC ENDOSCOPES | May 12, 2000 | Substantially Equivalent | N.M. BEALE CO. INC. |
| K001016 | GE LOGIQ 700 | Apr 24, 2000 | Substantially Equivalent | GE MEDICAL SYSTEMS |
| K994373 | HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4) | Mar 24, 2000 | Substantially Equivalent | ATL ULTRASOUND, INC. |
| K992305 | MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004 | Sep 08, 1999 | Substantially Equivalent | MEDI-STIM A/S |
| K982208 | IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER | Aug 27, 1999 | Substantially Equivalent | JOMED IMAGING LTD. |
| K992152 | GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF | Aug 17, 1999 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K984639 | THE S-VNA 5-8(B) DIAGNOSTIC ULTRASOUND TRANSDUCER | Jul 12, 1999 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K992155 | VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL TRANSDUCER, MODEL S-VAW 4-7 | Jul 08, 1999 | Substantially Equivalent | MEDISON AMERICA, INC. |
| K984562 | VIVOSONIC | Jun 08, 1999 | Substantially Equivalent | SONOTECH, INC. |
| K991236 | GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER, | Jun 02, 1999 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K983691 | SCANFLEX SOLID COUPLANT MEMBRANE | May 05, 1999 | Substantially Equivalent | SONOTECH, INC. |
| K990175 | SHEATHES (NON-LATEX), STERILE | Apr 21, 1999 | Substantially Equivalent | SHEATHING TECHNOLOGIES, INC. |
| K983985 | HYBRISONIC SHEATH | Feb 25, 1999 | Substantially Equivalent | SONOTECH, INC. |
| K990400 | LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM | Feb 24, 1999 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K982568 | BLADDERMANAGER PCI 5000 MODEL 1002 | Jan 25, 1999 | Substantially Equivalent | DIAGNOSTIC ULTRASOUND CORP. |
| K982329 | VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900) | Jan 14, 1999 | Substantially Equivalent | ENDOSONICS CORP. |
| K982323 | OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE | Dec 11, 1998 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K982610 | OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT) | Nov 16, 1998 | Substantially Equivalent | OLYMPUS OPTICAL, CO. |
| K982733 | OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE | Oct 28, 1998 | Substantially Equivalent | THE OLYMPUS OPTICAL CO. |
| K982725 | OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE | Oct 23, 1998 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K981069 | ULTRA-COVER PU-TRANSDUCER COVER | Sep 23, 1998 | Substantially Equivalent | INTERNATIONAL MEDICAL PRODUCTS B.V. |
| K981028 | ULTRA IMAGE AND ULTRA SCAN | Aug 21, 1998 | Substantially Equivalent | SONOTECH, INC. |
| K981434 | EUP-OL334 LAPARASCOPICPROBE | Jul 27, 1998 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K964001 | SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM | Apr 17, 1998 | Substantially Equivalent | MED INSTITUTE, INC. |
| K980091 | LUBRISCAN ULTRA SCAN GEL +, MODEL RG2-60 | Apr 09, 1998 | Substantially Equivalent | COSMACEUTICAL MARKETING, INC. |
| K974544 | ASU-1000 DIAGNOSTIC ULTRASOUND TRANSDUCER | Mar 18, 1998 | Substantially Equivalent | ALOKA CO., LTD. |
| K972771 | PHASED ARRAY TRANSDUCER - - PVF -375DT | Feb 11, 1998 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K974301 | CLK INT'L. SANITARY LATEX PROBE COVER, CLK ULTRASOUND PROBE COVER | Feb 06, 1998 | Substantially Equivalent | CLK INTL., INC. |
| K973713 | 22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR | Jan 23, 1998 | Substantially Equivalent | CARDIOVASCULAR DYNAMICS, INC. |
| K973958 | GENERAL PURPOSE ATL NEEDLE GUIDE KIT | Jan 22, 1998 | Substantially Equivalent | PROTEK MEDICAL PRODUCTS, INC. |
| K971116 | SONOS 5500 IMAGING SYSTEM | Jan 12, 1998 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K955893 | EVERYTIME TRANSFUCER COVER | Dec 30, 1997 | Substantially Equivalent | AMEDIC AB |
| K973622 | TRANSDUCER POSITIONER | Nov 26, 1997 | Substantially Equivalent | PROTEK MEDICAL PRODUCTS, INC. |
| K973079 | L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM | Nov 05, 1997 | Substantially Equivalent | ACUSON CORP. |
| K973362 | NEEDLE GUIDE/GRID | Oct 01, 1997 | Substantially Equivalent | PROTEK MEDICAL PRODUCTS, INC. |
| K971397 | VIEWCATH 3-D CATHETER PULLBACK | Aug 25, 1997 | Substantially Equivalent | QUINTON, INC. |
| K972152 | DEVMED STEPPING AND STABILIZING SYSTEM | Aug 15, 1997 | Substantially Equivalent | DEVMED CORP. |
| K955668 | INTRACAVITY NEEDLE GUIDE KIT | Jul 30, 1997 | Substantially Equivalent | ARLANDA MEDICINSKA INSTRUMENT CO. AB |
| K972672 | BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY | Jul 29, 1997 | Substantially Equivalent | BARZELL-WHITMORE MAROON BELLS, INC. |
| K972348 | HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM | Jul 24, 1997 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K971942 | SLED, FINGER, HANDLE | Jul 23, 1997 | Substantially Equivalent | BIOSOUND ESAOTE, INC. |
| K971722 | TRANS VAGINAL NEEDLE GUIDE | Jul 10, 1997 | Substantially Equivalent | PROTEK MEDICAL PRODUCTS, INC. |
| K971700 | BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER | Jul 09, 1997 | Substantially Equivalent | BIOSOUND, INC. |
| K970515 | GENERAL PURPOSE LATEX TRANSDUCER COVERS | Jun 20, 1997 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K970514 | DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE | Jun 20, 1997 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K970513 | GENERAL PURPOSE TRANDUCER COVER | Jun 20, 1997 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K970049 | BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/ | Jun 20, 1997 | Substantially Equivalent | CARDIOVASCULAR IMAGING SYSTEMS, INC. |
| K971115 | GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDE | Jun 13, 1997 | Substantially Equivalent | PROTEK MEDICAL PRODUCTS, INC. |
| K964549 | ALOKA UST-5258-5 DIAGNOSTIC ULTRASOUND TRANSDUCER | Jun 03, 1997 | Substantially Equivalent | ALOKA CO., LTD. |
| K963989 | P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE | Apr 24, 1997 | Substantially Equivalent | CARDIOVASCULAR DYNAMICS, INC. |
| K970034 | SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM | Mar 17, 1997 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K964865 | PVK-720ST ENDOCAVITARY TRANSDUCER | Mar 10, 1997 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K970047 | PHASED ARRAY TRANSDUCER - - PSK-20CT | Mar 04, 1997 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K964658 | OASIS | Feb 14, 1997 | Substantially Equivalent | SONOTECH, INC. |
| K963831 | SHEATHES (NON-LATEX) | Feb 10, 1997 | Substantially Equivalent | MEDICAL RESOURCES |
| K961974 | FG-36UX, ULTRASOUND UPPER GI FIBERSCOPE | Feb 10, 1997 | Substantially Equivalent | PENTAX PRECISION INSTRUMENT CORP. |
| K963302 | TAYMAN MEDICAL, INC. STEPPING & STABILIZING SYSTEM | Feb 06, 1997 | Substantially Equivalent | TAYMAN MEDICAL, INC. |
| K961002 | DIASONICS ITNRAOPERATIVE PROBES | Jan 22, 1997 | Substantially Equivalent | DIASONICS ULTRASOUND |
| K962840 | ECOLOTION TRANSMISSION AND MASSAGE LOTION | Dec 23, 1996 | Substantially Equivalent | ECO-MED PHARMACEUTICALS, INC. |
| K962093 | ULTRAMIX | Dec 23, 1996 | Substantially Equivalent | SONOTECH, INC. |
| K963169 | RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL | Nov 12, 1996 | Substantially Equivalent | RAPID-AID LTD./LTEE |
| K951567 | CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE | Oct 25, 1996 | Substantially Equivalent | CARDIOMETRICS, INC. |
| K962293 | ENDOSONICS AUTOMATIC PULL BACK DEVICE | Sep 16, 1996 | Substantially Equivalent | ENDOSONICS CORP. |
| K961692 | SONOSCAN | Aug 22, 1996 | Substantially Equivalent | SONOTECH, INC. |
| K961757 | ECOGEL 100 ULTRASOUND GEL | Jul 25, 1996 | Substantially Equivalent | ECO-MED PHARMACEUTICALS, INC. |
| K953716 | INTRACAVITY TRANSDUCERS | Apr 17, 1996 | Substantially Equivalent | BIOSOUND, INC. |
| K953819 | DIAGNOSTIC ULTRASOUND TRANDUCER | Mar 01, 1996 | Substantially Equivalent | BIOSOUND, INC. |
| K953759 | DIAGNOSTIC ULTRASOUND TRANSDUCER | Mar 01, 1996 | Substantially Equivalent | BIOSOUND, INC. |
| K955246 | ECOGEL 200 ULTRASOUND GEL | Feb 21, 1996 | Substantially Equivalent | ECO-MED PHARMACEUTICALS, INC. |
| K955458 | ULTRASOUND PROBE BIOPSY ACCESSORIES | Feb 12, 1996 | Substantially Equivalent | BIOSOUND, INC. |
| K952892 | OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908) | Feb 12, 1996 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K953579 | TEE PROBE | Feb 02, 1996 | Substantially Equivalent | BIOSOUND, INC. |
| K951723 | GE B510 TRANSDUCER | Nov 14, 1995 | Substantially Equivalent | GE MEDICAL SYSTEMS |
| K953430 | ULTRASOUND PROBE BIOPSY ACCESSORIES | Oct 24, 1995 | Substantially Equivalent | BIOSOUND, INC. |
| K941935 | LP-12 LAPAROSCOPIC PROBE | Sep 18, 1995 | Substantially Equivalent | BIOSOUND, INC. |
| K946300 | DOPPLEX SURGICAL PROBES | Jul 26, 1995 | Substantially Equivalent | HNE HEALTHCARE, INC. |
| K951145 | VMI 1000 SURGICAL PACEOMETER | Jun 19, 1995 | Substantially Equivalent | VISION MEDICAL INSTRUMENTS, INC. |
| K944017 | OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM | Jun 13, 1995 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K944287 | 7050 ULTRASOUND IMAGING SYSTEM | Jun 02, 1995 | Substantially Equivalent | BIOSOUND, INC. |
| K945796 | SHARPLAN USIGHT 9010 LAPAROSCOPIC ULTRASOUND SYSTEM | May 24, 1995 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K945320 | TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL | May 11, 1995 | Substantially Equivalent | TETRA CORP. |
| K935994 | PW DOPPLER VASCULAR PROBES | May 11, 1995 | Substantially Equivalent | KOVEN TECHNOLOGY, INC. |
| K945318 | TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA | May 05, 1995 | Substantially Equivalent | TETRA CORP. |
| K945319 | TETRAD MODEL BS18, ENDOSURGICAL NEEDLE GUIDE ATTACHMENT | May 04, 1995 | Substantially Equivalent | TETRA CORP. |
| K944610 | OLYMPUS ULTRASONIC PROBES | Apr 10, 1995 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K942296 | V5M | Mar 02, 1995 | Substantially Equivalent | ACUSON CORP. |
| K935595 | ACUSON MODEL 3001 | Mar 02, 1995 | Substantially Equivalent | ACUSON CORP. |
| K921695 | ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS | Feb 23, 1995 | Substantially Equivalent | PARKER LABORATORIES, INC. |
| K930052 | SIEMENS QUANTUM 7E11 TRANSRECTAL TRANSDUCER | Jan 04, 1995 | Substantially Equivalent | SIEMENS QUANTUM, INC. |
| K943637 | SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM | Dec 29, 1994 | Substantially Equivalent | ALOKA CO., LTD. |
| K940108 | DIAGNOSTIC ULTRASOUND IMAGING CATHETER | Dec 07, 1994 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K940671 | INTERSPEC APOGEE RX400 ULTRASOUND IMAGING SYSTEM AND DOPPLER ULTRASOUND FLOWMETER | Nov 22, 1994 | Substantially Equivalent | INTERSPEC, INC. |
| K940804 | SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATION | Jun 10, 1994 | Substantially Equivalent | PERIPHERAL SYSTEMS GROUP |
| K933663 | MODIFICATION OF ACUSON V510B TRANSDUCER | Jan 21, 1994 | Substantially Equivalent | ACUSON CORP. |
| K925869 | SHEATHES, STERILE SHEATHES | Jan 06, 1994 | Substantially Equivalent | MAYER LABORATORIES |
| K932777 | SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETER | Oct 07, 1993 | Substantially Equivalent | PERIPHERAL SYSTEMS GROUP |
| K925434 | SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A | Sep 30, 1993 | Substantially Equivalent | KRETZ TECHNIK |
| K932536 | CARDIOMETRICS FLOWIRE & FLOMAP | Sep 28, 1993 | Substantially Equivalent | CARDIOMETRICS, INC. |
| K925081 | SURFAS | Sep 28, 1993 | Substantially Equivalent | D.O. WEAVER AND CO. |
| K926108 | VINGMED SOUND COLOR FLOW MAPPING SYSTEM, CFM-800 | Sep 24, 1993 | Substantially Equivalent | VINGMED SOUND, INC. |
| K920882 | ACUSON V714 TRANSDUCER | Mar 26, 1993 | Substantially Equivalent | ACUSON CORP. |
| K925486 | UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS. | Feb 12, 1993 | Substantially Equivalent | ALOKA CO., LTD. |
| K924980 | CATHSCANNER VISIONS MICRORAIL ULTRA IMAG CATH | Jan 15, 1993 | Substantially Equivalent | ENDOSONICS CORP. |
| K923348 | OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED | Dec 10, 1992 | Substantially Equivalent | ZEISS HUMPHREY SYSTEM |
| K921341 | ACUSON V714OR TRANSDUCER | Nov 27, 1992 | Substantially Equivalent | ACUSON CORP. |
| K915696 | INTERSPEC APOGEE ENDO-V PROBE AND NEEDLE GUIDE | Nov 24, 1992 | Substantially Equivalent | INTERSPEC, INC. |
| K915647 | DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250 | Nov 09, 1992 | Substantially Equivalent | PIE MEDICAL EQUIPMENT B.V. |
| K913890 | SONICATH(TM) 3.5 F, 20 MHZ | Nov 09, 1992 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K922549 | UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35 | Sep 21, 1992 | Substantially Equivalent | ALOKA CO., LTD. |
| K911435 | CPA/3.5 MHZ PROBE | Sep 11, 1992 | Substantially Equivalent | DIASONICS, INC. |
| K902515 | ACUSON S228 TRANSDUCER FOR TRANSCRANIAL COLOR DOPP | Sep 04, 1992 | Substantially Equivalent | ACUSON CORP. |
| K912364 | ELECTRONIC ULTRASOUND SCANNER EUB-315, MODIFIED | Aug 26, 1992 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K922184 | HP SONOS 100 CF ULTRASOUND IMAGING SYSTEM | Jul 30, 1992 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K921750 | CVIS INSIGHT III SYSTEM | Jul 13, 1992 | Substantially Equivalent | CARDIOVASCULAR IMAGING SYSTEMS, INC. |
| K921631 | CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL | Jul 02, 1992 | Substantially Equivalent | CARDIOVASCULAR IMAGING SYSTEMS, INC. |
| K915860 | LINEAR PERIPHERALVASCULAR ULTRSOUND PROBE | Jul 02, 1992 | Substantially Equivalent | BIOSOUND, INC. |
| K921563 | CARDIOMETRICS FLOWIRE/FLOMAP SYSTEM | Jul 01, 1992 | Substantially Equivalent | CARDIOMETRICS, INC. |
| K911916 | ACUSON C366 TRANSDUCER | Jun 18, 1992 | Substantially Equivalent | ACUSON CORP. |
| K921148 | CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE | Jun 16, 1992 | Substantially Equivalent | CARDIOVASCULAR IMAGING SYSTEMS, INC. |
| K921147 | CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE | Jun 16, 1992 | Substantially Equivalent | CARDIOVASCULAR IMAGING SYSTEMS, INC. |
| K921036 | SONOS 100 ULTRASOUND IMAGING SYSTEM | May 29, 1992 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K920307 | AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION | May 19, 1992 | Substantially Equivalent | AUSONICS PTY LTD. |
| K910966 | SECTOR TRANSDUCER MODEL NO. AWP3.5/A | Apr 17, 1992 | Substantially Equivalent | KRETZTECHNIK AG |
| K920678 | ULTRASOUND IMAGAING SYSTEM AND DOPPLER FLOWMETER | Apr 02, 1992 | Substantially Equivalent | INTERSPEC, INC. |
| K914006 | BIPLANE TRANSRECTAL PROBE | Apr 02, 1992 | Substantially Equivalent | BIOSOUND, INC. |
| K905200 | SACA, 3.5 MHZ PROBE | Apr 02, 1992 | Substantially Equivalent | DIASONICS, INC. |
| K913798 | SONOLAYER ALPHA, MODEL SSH-140A | Apr 01, 1992 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K913472 | LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM | Mar 13, 1992 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K903562 | CW DOPPLER 2.25 MHZ PROBE | Mar 02, 1992 | Substantially Equivalent | DIASONICS, INC. |
| K913941 | PSG(TM) 20 GUAGE DOPPLER NEEDLE | Feb 27, 1992 | Substantially Equivalent | PERIPHERAL SYSTEMS GROUP |
| K910850 | PSF-50ET | Jan 29, 1992 | Substantially Equivalent | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| K912776 | CARDIOMETRICS FLOWIRE/FLOMAP DOPPLER ULTRASOUND | Jan 09, 1992 | Substantially Equivalent | CARDIOMETRICS, INC. |
| K911116 | INTERSON ENDOCAVITY PROBE/KONTRON ULTRASOUND SYST | Dec 20, 1991 | Substantially Equivalent | INTERSON CORP. |
| K913746 | SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM | Dec 17, 1991 | Substantially Equivalent | PERIPHERAL SYSTEMS GROUP |
| K911117 | INTERSON ENDOCAVITY PROBE FOR ATL ULTRASOUND SYST | Dec 17, 1991 | Substantially Equivalent | INTERSON CORP. |
| K911115 | INTERSON TRANSRECTAL PROBE/ATL ULTRASOUND SYSTEM | Dec 17, 1991 | Substantially Equivalent | INTERSON CORP. |
| K911113 | INTERSON TRANSRECTAL PROBE/KONTRON ULTRASOUND SYST | Dec 17, 1991 | Substantially Equivalent | INTERSON CORP. |
| K912088 | BIOPSY ACCESSORIES FOR ULTRASOUND PROBES | Dec 05, 1991 | Substantially Equivalent | BIOSOUND, INC. |
| K912361 | SI-450/ILUS (INTRALUMINAL ULTRASOUND) | Dec 02, 1991 | Substantially Equivalent | SIEMENS ULTRASOUND, INC. |
| K912600 | INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER | Nov 19, 1991 | Substantially Equivalent | INTERTHERAPY, INC. |
| K911114 | INTERSON ENDOCAVITY PROBE/ALOKA ULTRASOUND SYSTEM | Nov 19, 1991 | Substantially Equivalent | INTERSON CORP. |
| K911767 | ACUSON V510 TRANSDUCER | Oct 31, 1991 | Substantially Equivalent | ACUSON CORP. |
| K911043 | HEMISPHERE MULTIPLANE ENDORECTAL PROBE | Oct 09, 1991 | Substantially Equivalent | PIE MEDICAL EQUIPMENT B.V. |
| K911044 | 7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1) | Oct 07, 1991 | Substantially Equivalent | PIE MEDICAL EQUIPMENT B.V. |
| K911414 | CVIS INSIGHT IMAGING CATHETERS | Sep 11, 1991 | Substantially Equivalent | CARDIOVASCULAR IMAGING SYSTEMS, INC. |
| K912363 | ELECTRONIC ULTRASOUND SCAN MODELS EUP-U12/012T/TC3 | Aug 27, 1991 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K903984 | CW DOPPLER/4.5 MHZ | Jun 14, 1991 | Substantially Equivalent | DIASONICS, INC. |
| K911073 | PROBE REFILL KIT | Jun 06, 1991 | Substantially Equivalent | INTERSPEC, INC. |
| K911309 | UST-974-5 CONVEX TRANSDUCER | Apr 29, 1991 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K900880 | OLYMPUS JF-UM3-7.5/-12 AND CF-UM3-7.5/-12 | Apr 29, 1991 | Substantially Equivalent | OLYMPUS CORP. |
| K910268 | TRANSDUCERS, EUP-C318/V33/F334/CC331/B31/032T | Apr 15, 1991 | Substantially Equivalent | HITACHI MEDICAL CORP. |
| K904459 | C544 TRANSDUCER | Mar 29, 1991 | Substantially Equivalent | ACUSON CORP. |
| K904902 | SMA 26 TRANSDUCER | Mar 26, 1991 | Substantially Equivalent | PAREXEL INTL. CORP. |
| K904901 | L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC | Mar 26, 1991 | Substantially Equivalent | PAREXEL INTL. CORP. |
| K910669 | 5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU | Mar 15, 1991 | Substantially Equivalent | SIEMENS ULTRASOUND, INC. |
| K910529 | 7.5 MHZ PEDIATRIC TRANSESOPHAGEAL ECHO (TEE) TRANS | Mar 15, 1991 | Substantially Equivalent | SIEMENS ULTRASOUND, INC. |
| K903561 | QUICK-CLIP NEEDLE GUIDE | Mar 05, 1991 | Substantially Equivalent | ACUSON CORP. |
| K905535 | ALOKA UST-952DP-5 ENDOVAGINAL TRANSDUCER | Feb 28, 1991 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K902728 | 7.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815) | Feb 13, 1991 | Substantially Equivalent | AUSONICS PTY LTD. |
| K905252 | ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM | Feb 12, 1991 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K905391 | UST-969-5 CONVEX TRANSDUCER | Jan 31, 1991 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K904665 | MODEL IW17.5A INTRA OPERATIVE TRANSDUCER | Jan 11, 1991 | Substantially Equivalent | KRETZTECHNIK AG |
| K902926 | COLOR VELOCITY IMAGING (CVI) OPTION FOR PLATINUM | Nov 26, 1990 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. |
| K902245 | SONICATH(TM) 9F, 12 MHZ | Oct 09, 1990 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K900155 | INTERSPEC 2 MHZ, TRANSCRANIAL PULSED WAVE DOPPLER | Oct 05, 1990 | Substantially Equivalent | INTERSPEC, INC. |
| K900683 | SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND | Aug 31, 1990 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K902070 | RADIUS AND SONOCHROME | Aug 28, 1990 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K897073 | ADDITIONAL TRANSDUCERS FOR USE W/SDL 300 | Aug 21, 1990 | Substantially Equivalent | SHIMADZU CORP. |
| K896644 | ADDITIONAL TRANSDUCERS FOR USE WITH SDU 500 | Aug 21, 1990 | Substantially Equivalent | SHIMADZU CORP. |
| K901725 | ADD'L TRANSDUCER FOR USE W/THE COMBISON 310A | Aug 15, 1990 | Substantially Equivalent | KRETZTECHNIK AG |
| K901655 | 1 TRANSDUCER FOR COMBISON 310A | Jul 20, 1990 | Substantially Equivalent | KRETZTECHNIK AG |
| K893863 | ACUSON L538 TRANSDUCER | May 23, 1990 | Substantially Equivalent | ACUSON COMPUTED SONOGRAPHY |
| K894763 | FUJINON EDU SYSTEM | May 22, 1990 | Substantially Equivalent | FUJINON, INC. |
| K900555 | INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA. | May 02, 1990 | Substantially Equivalent | INTERSON CORP. |
| K896038 | B-SCAN 10 MHZ PROBE | Apr 23, 1990 | Substantially Equivalent | TEKNAR, INC. |
| K890532 | EUP-C321 5.0MHZ CONVEX TYPE PROBE | Apr 13, 1990 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K890531 | EUP-F124 5.0 MHZ CONVEX ARRAY FINGER TOP PROBE | Apr 13, 1990 | Substantially Equivalent | HITACHI MEDICAL CORP. OF AMERICA |
| K897098 | SIEMENS ENDO-P-PROBE | Feb 23, 1990 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K895359 | ADMS MULTIPLANE RECTAL PROBE | Nov 22, 1989 | Substantially Equivalent | AVALON TECHNOLOGY CORP. |
| K894547 | RADIUS CF | Nov 22, 1989 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K895100 | ECHO GEL (RAINFOREST) | Nov 03, 1989 | Substantially Equivalent | LEAD-LOK, INC. |
| K874943 | SONAR-AID(R) ULTRASOUND STANDOFF PAD | Jul 25, 1988 | Substantially Equivalent | GEISTLICH-PHARMA |
| K874922 | ACUSON TRANSPERINEAL NEEDLE GUIDE | Feb 19, 1988 | Substantially Equivalent | ACUSON COMPUTED SONOGRAPHY |
| K874860 | ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA. | Feb 17, 1988 | Substantially Equivalent | ACUSON COMPUTED SONOGRAPHY |
| K870899 | EZU-PC 2A/5.0 & 3A/3.5MHZ, EUP-CD 121/5.0 CONVEX | Dec 30, 1987 | Substantially Equivalent | BIOSOUND, INC. |
| K870967 | ADMS TRANSRECTAL 7.5 MHZ PROBE | Sep 29, 1987 | Substantially Equivalent | DIASONICS, INC. |
| K871432 | 3.0 MHZ PHASED ARRAY SCANHEAD W/2.0 MHZ SIDEARM CW | Aug 07, 1987 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K863269 | SONOLAYER - V, SSA-100A. | Jul 22, 1987 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K871609 | ULTRASOUND TRANSDUCER SHEATHS, STERILE | Jul 15, 1987 | Substantially Equivalent | AMEDIC USA |
| K870748 | 7.5 MHZ TRANSRECTAL (ENDORECTAL) PROBE | Apr 10, 1987 | Substantially Equivalent | PHILIPS ULTRASOUND, INC. |
| K870038 | TRT TRANS-RECTAL TRANSDUCER | Mar 30, 1987 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K863708 | 7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12 | Mar 23, 1987 | Substantially Equivalent | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| K864812 | DIASONICS SPA 3.5 MHZ, 30MM PROBE | Mar 10, 1987 | Substantially Equivalent | DIASONICS, INC. |
| K864758 | DIASONICS SPA 5.O 27MM PROBE | Mar 10, 1987 | Substantially Equivalent | DIASONICS, INC. |
| K864222 | SERIES 620 RECTAL PROBE COVER | Mar 04, 1987 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K863364 | DIAGNOSTIC ULTRASONIC TRANSDUCER | Feb 27, 1987 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K862686 | KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEM | Feb 27, 1987 | Substantially Equivalent | KONTRON INSTRUMENTS, INC. |
| K855247 | INTEROPERATIVE LINEAR/SECTOR ULTRASOUND SCANNER | Feb 19, 1987 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K863700 | RT2800(115V)/H4008C AND RT2800(220/240V)/H4008CE | Feb 10, 1987 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K864136 | 260SL IMAGING SYSTEM SMALL PARTS PROBES | Jan 27, 1987 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K864135 | 280SL IMAGING SYSTEM SMALL PARTS PROBES | Jan 27, 1987 | Substantially Equivalent | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
| K862211 | ULTRASOUND TRANSDUCER ASSEMBLY | Jan 02, 1987 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K862844 | 7.5 MHZ LINEAR PROBE, CAT. NO. H4221H | Nov 25, 1986 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K862911 | BI-PLANE TRANSRECTAL PROBE NUMBER H4221T | Oct 31, 1986 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K860009 | 5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM | Aug 20, 1986 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K860568 | ULTRASONIC IMAGING SYSTEM (MODIFIED) | Aug 11, 1986 | Substantially Equivalent for Some Indications | INTERSPEC, INC. |
| K861358 | PS SYSTEM WITH SD-200 DOPPLER | Jul 30, 1986 | Substantially Equivalent for Some Indications | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K860531 | SONOLAYER-L, SAL-38A, WITH SCANNER SAL-38AS | Jul 18, 1986 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K861237 | VASOVIEW DUPLEX IMAGING SYSTEM | Jul 14, 1986 | Substantially Equivalent for Some Indications | SONICAID, INC. |
| K861109 | CW DOPPLER STATIC TRANSDUCERS | Jul 08, 1986 | Substantially Equivalent for Some Indications | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K861228 | 7.5 MHZ LINEAR PROBE (ULTRASONIC TRANSDUCER) | Jul 03, 1986 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K854337 | SDL-300 | Jun 20, 1986 | Substantially Equivalent | SHIMADZU CORP. |
| K860553 | STORZ, ALPHA II BIOMETRIC RULER | Jun 16, 1986 | Substantially Equivalent | STORZ INSTRUMENT CO. |
| K860361 | DIASONICS 3.5 GWA 30MM PROBE | May 27, 1986 | Substantially Equivalent | DIASONICS, INC. |
| K860281 | CONVEX PROBE, PVE-382M | May 27, 1986 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K860235 | MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER | May 15, 1986 | Substantially Equivalent | HOFFREL INSTRUMENTS, INC. |
| K843247 | KOI PACHYMETER | Apr 30, 1986 | Substantially Equivalent | KOI, INC. |
| K844772 | 6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU | Apr 17, 1986 | Substantially Equivalent | PHILIPS MEDICAL SYSTEMS, INC. |
| K860494 | 7.5 MHZ SHORT FOCUS FLUID OFFSET PROBE #041-726T | Mar 26, 1986 | Substantially Equivalent | AUSONICS PTY LTD. |
| K854787 | ACUSON L538 TRANSDUCER | Mar 03, 1986 | Substantially Equivalent for Some Indications | ACUSON COMPUTED SONOGRAPHY |
| K853966 | ACUSON L312 TRANSDUCER | Feb 20, 1986 | Substantially Equivalent | ACUSON COMPUTED SONOGRAPHY |
| K854429 | ACUSON NEEDLE GUIDE SYSTEM | Feb 07, 1986 | Substantially Equivalent | ACUSON COMPUTED SONOGRAPHY |
| K854788 | ACUSON AL538 TRANSDUCER | Jan 15, 1986 | Substantially Equivalent | ACUSON COMPUTED SONOGRAPHY |
| K854786 | ACUSON BL538 TRANSDUCER | Jan 15, 1986 | Substantially Equivalent | ACUSON COMPUTED SONOGRAPHY |
| K854785 | ACUSON AL558 TRANSDUCER | Jan 15, 1986 | Substantially Equivalent | ACUSON COMPUTED SONOGRAPHY |
| K852947 | ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M | Jan 06, 1986 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K853249 | RT3600(115V) RT3600(220/240V) | Dec 09, 1985 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K852159 | NEW OPTIONAL PROBES FOR SSA-90A | Dec 02, 1985 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K852090 | SONOLAYER-L, SAL-77A | Dec 02, 1985 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K853755 | ACOUSTICALLY-COUPLED ELECTRONIC PHANTOM 84-410 | Nov 26, 1985 | Substantially Equivalent | VICTOREEN, INC. |
| K853852 | MULTISCAN 7 | Nov 19, 1985 | Substantially Equivalent | MULTISCAN, INC. |
| K852974 | ACUSON RADIOLOGY DOPPLER ACCESSORY | Oct 24, 1985 | Substantially Equivalent for Some Indications | ACUSON COMPUTED SONOGRAPHY |
| K851526 | CONVEX PROBE, PVE-393M | Sep 23, 1985 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K851240 | SONOLAYER-L SAL-32B | Sep 23, 1985 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K851036 | SONOLAYER-V, SSA-90A | Sep 17, 1985 | Substantially Equivalent | TOSHIBA MEDICAL SYSTEMS |
| K852132 | MODEL 21225A CW COPPLER/IMAGING TRANSDUCER | Aug 19, 1985 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K844031 | SONOMED TECH OPHTHALMIC B-SCAN B-3000 | May 22, 1985 | Substantially Equivalent | SONOMED TECHNOLOGY, INC. |
| K842687 | BIOMEDICS BLADDER SCANNER | Apr 08, 1985 | Substantially Equivalent | BIOMEDICS |
| K850422 | ATS ACOUSTIC STANDOFF - WATER BAG | Mar 27, 1985 | Substantially Equivalent | ATS LABORATORIES, INC. |
| K843573 | CIVCO-SUPER SCAN/BIOPSY GUIDE | Dec 13, 1984 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K833224 | BIFOCAL 3.0MHZ | Nov 29, 1983 | Substantially Equivalent | ADR ULTRASOUND |
| K812776 | TRANSDUCER ANTISEPTIC TOWELETTE | Jan 25, 1982 | Substantially Equivalent | ECHO LABORATORIES, INC. |
| K812929 | 3.5 MHZ BIOPSY TRANSDUCER | Nov 24, 1981 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K812301 | VARIABLE FOCUS 3.5 MHZ TRANSDUCER | Nov 16, 1981 | Substantially Equivalent | ADR ULTRASOUND |
| K811843 | BIOPSY TRANSDUCER | Aug 25, 1981 | Substantially Equivalent | SIEMENS GAMMASONICS, INC. |
| K810748 | 7.5 MHZ WP TRANSDUCER | Jun 19, 1981 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K810749 | 5 MHZ TRANSDUCER | Apr 17, 1981 | Substantially Equivalent | GENERAL ELECTRIC CO. |
| K802438 | MARK V DUPLEX ULTRASONIC SCAN SYS. | Jan 21, 1981 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K801973 | IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA | Oct 23, 1980 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K801971 | IN-LINE SCAN HEAD MODIFICATION MARK III | Oct 23, 1980 | Substantially Equivalent | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| K781649 | ULTRASONIC TRANSDUCERS | Dec 07, 1978 | Substantially Equivalent | ECHO LABORATORIES, INC. |
| K780651 | ULTRASONIC DIAGNOSTIC TRANSDUCER | May 09, 1978 | Substantially Equivalent | HOFFREL INSTRUMENTS, INC. |
FEI Numbers
This FDA classification entry is associated with 388 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 389 registration numbers. Click on an entry to view related FDA registrations.