Transducer, Ultrasonic, Diagnostic
FDA product code ITX · Class II (moderate risk) · 21 CFR 892.1570 · Radiology
414510(k) clearances
0PMA approvals
138recalls
Manufacturers
- CIVCO Medical Instruments Co., Inc. 15
- Biosound, Inc. 13
- Acuson Corp. 11
- General Electric Co. 11
- Boston Scientific Corporation 10
- Acuson Computed Sonography 10
- Toshiba America Medical Systems, In.C 9
- Toshiba Medical Systems 9
- Aloka Co., Ltd. 8
- Sonotech, Inc. 8
- Diasonics, Inc. 8
- Olympus America, Inc. 8
- Hewlett-Packard Co. 7
- Siemens Medical Solutions USA, Inc. 7
- Advanced Technology Laboratories, Inc. 7
- Interson Corp. 6
- Ge Medical Systems Information Technologies 6
- Hitachi Medical Corp. of America 6
- Interspec, Inc. 6
- Cardiovascular Imaging Systems, Inc. 6
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261170 | BA-004CCITX · Traditional | Fujifilm Corporation | 08/12/2026SE |
| K254143 | EM-TECH Passive Ultrasound Probe StrapITX · Traditional | EM-TECH Solutions, Inc. | 08/10/2026SE |
| K260161 | SmartGuide Disposable Guides and GridsITX · Traditional | UC-CARE , Ltd. | 07/30/2026SE |
| K262474 | ND Needle Guidance SystemITX · Traditional | Accurate Access, LLC | 07/27/2026SE |
| K261014 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 07/24/2026SE |
| K250883 | Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R)ITX · Traditional | Olympus Medical Systems Corporation | 09/18/2025SE |
| K250762 | Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R)ITX · Traditional | Olympus Medical Systems Corporation | 07/11/2025SE |
| K250524 | Mendaera Guidance SystemITX · Traditional | Mendaera, Inc. | 07/02/2025SE |
| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 06/13/2025SE |
| K241662 | Ultrasound Transducer CoverITX · Traditional | Vitrolife Sweden AB | 08/30/2024SE |
| K233965 | UltraDrape UGPIV Barrier and Securement (34-15)ITX · Traditional | Parker Laboratories, Inc. | 08/15/2024SE |
| K241615 | Transducer Probe CoverITX · Special | Hony Medical Co., Ltd. | 07/03/2024SE |
| K233109 | TP Pivot Pro Needle GuideITX · Traditional | Civco Medical Solutions | 12/22/2023SE |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)ITX · Traditional | FUJIFILM Healthcare Americas Corporation | 12/13/2023SE |
| K231783 | VitroPROITX · Special | CIVCO Medical Instruments Co., Inc. | 11/14/2023SE |
| K223689 | Disposable Needle Guides and GridsITX · Traditional | Advance Medical Designs, Inc. | 08/02/2023SE |
| K222460 | Intraoperative Ultrasound Probe CoverITX · Traditional | Exact Medical Manufacturing | 05/12/2023SE |
| K221278 | Transducer Probe CoverITX · Traditional | Hony Medical Co., Ltd. | 01/11/2023SE |
| K222052 | VitroPROITX · Traditional | CIVCO Medical Instruments Co., Inc. | 11/22/2022SE |
| K213087 | Natural Rubber Latex Ultrasound Transducer Probe CoversITX · Traditional | Global Protection Corp. | 06/07/2022SE |
| K211270 | CIV-Clear coverITX · Traditional | CIVCO Medical Instruments Co., Inc. | 09/13/2021SE |
| K211969 | EMM Ultrasonic Transducer CoverITX · Traditional | Exact Medical Manufacturing | 08/13/2021SE |
| K201425 | Disposable Intraoperative Probe (DIOP8)ITX · Traditional | Huntleigh Healthcare Limited | 02/19/2021SE |
| K202035 | Vscan AirITX · Traditional | GE Medical Systems Ultrasound and Primary Care… | 11/20/2020SE |
| K191491 | EZ-CoverITX · Traditional | Medxpress.Pro | 06/05/2020SE |
| K200733 | Opticross 35 15 MHz Peripheral Imaging CatheterITX · Special | Boston Scientific Corporation | 04/17/2020SE |
| K190802 | Envision ultrasound pad and coverITX · Traditional | Civco Medical Solutions | 05/24/2019SE |
| K171272 | Cook-Swartz Doppler Flow ProbeITX · Traditional | Cook Incorporated | 07/17/2018SE |
| K180970 | Disposable guides KDNG00ITX · Traditional | Koelis | 07/10/2018SE |
| K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and…ITX · Traditional | Koelis | 07/31/2017SE |
| K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe…ITX · Traditional | CIVCO Medical Instruments Co., Inc. | 06/09/2017SE |
| K170741 | GTK Disposable Needle GuidesITX · Traditional | Geotek Medikal Ltd Sti | 06/01/2017SE |
| K171348 | Pinpoint GT Needle Guide KitsITX · Special | C.R. Bard, Inc. | 05/22/2017SE |
| K170338 | A-ViewITX · Traditional | Stroke2prevent B.V. | 05/16/2017SE |
| K163502 | iSR'obot Biopsy KitITX · Traditional | Biobot Surgical Pte., Ltd. | 05/16/2017SE |
| K152126 | UST-5550-R; UST-5536-R; L43KITX · Traditional | Hitachi Aloka Medical America, Inc. | 08/17/2016SE |
| K160806 | Verza Guidance SystemITX · Traditional | CIVCO Medical Instruments Co., Inc. | 08/05/2016SE |
| K160414 | Precision Point Biopsy Needle GuideITX · Traditional | Corbin Clinical Resources, LLC | 08/01/2016SE |
| K153212 | Sheathes Ultrasound Probe CoversITX · Traditional | Sheathing Technologies, Inc. | 03/04/2016SE |
| K152403 | Permanent Sled BagITX · Special | Boston Scientific | 09/22/2015SE |
| K142618 | Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System…ITX · Special | Hitachi Aloka Medical America, Inc. | 10/16/2014SE |
| K141334 | Reusable GuideITX · Traditional | Koelis | 07/11/2014SE |
| K140854 | Intra-Operative Ultrasound TransducerITX · Traditional | Hitachi Aloka Medical, Ltd. | 06/11/2014SE |
| K141093 | 6VT-D Ultrasound TransducerITX · Traditional | Ge Vingmed Ultrasound AS | 05/15/2014SE |
| K131161 | EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch…ITX · Traditional | CIVCO Medical Instruments Co., Inc. | 09/17/2013SE |
| K131528 | Non-Pyrogenic Ultrasound Transducer CoverITX · Traditional | CIVCO Medical Instruments Co., Inc. | 06/11/2013SE |
| K123424 | MDU5 Plus Sterile BagITX · Traditional | Boston Scientific Corp | 02/20/2013SE |
| K122921 | C1-6-D Ultrasound TransducerITX · Special | GE Healthcare | 10/05/2012SE |
| K122515 | C2-9-D Ultrasound TransducerITX · Special | GE Healthcare | 09/11/2012SE |
| K121062 | Vivid I Diagnostic Ultrasound System, Vivid Q Diagnostic Ultrasound SystemITX · Traditional | Ge Medical System Israel , Ltd. | 08/17/2012SE |
| K121807 | V5MS TransducerITX · Special | Siemens Medical Solutions USA, Inc. | 07/10/2012SE |
| K113832 | Soniceye Ultrasound TransducerITX · Abbreviated | Blacktoe Medical Iii, Inc. | 03/06/2012SE |
| K111426 | Euclid (TM) Tier 1-GW Access SystemITX · Traditional | Houston Medical Robotics | 03/01/2012SE |
| K120156 | Pureimage Ultrasound Transmission GelITX · Traditional | Medline | 02/08/2012SE |
| K110752 | Highland Instruments Ces and Tus Instrument HolderITX · Traditional | Highland Instruments | 06/28/2011SE |
| K101952 | Konix Ultrasound GelITX · Traditional | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | 05/27/2011SE |
| K111021 | Cubescan / BIOCON-700ITX · Traditional | Mcube Technology Co., Ltd. | 04/27/2011SE |
| K110999 | Digital Ultrasonic Diagnostic Imaging SystemITX · Traditional | Edan Instruments, Inc. | 04/26/2011SE |
| K110920 | UF-760AGITX · Traditional | Fukuda Denshi Co., Ltd. | 04/08/2011SE |
| K110202 | Fujifilm Diagnostic Ultrasound System Fazone CBITX · Traditional | Fujifilm Medical System U.S.A., Inc. | 02/08/2011SE |
| K103629 | PET-512MC Transesophageal TransducerITX · Traditional | Toshiba America Medical Systems, In.C | 02/02/2011SE |
| K110020 | Terason T3200 Ultrasound SystemITX · Traditional | Teratech Corp. | 01/20/2011SE |
| K103645 | Aplio XG Diagnostic Ultrasound SystemITX · Special | Toshiba Medical Systems Corporation, Japan | 01/12/2011SE |
| K103722 | The Sonoace R5 Diagnostic Ultrasound SystemITX · Traditional | Medison Co., Ltd. | 01/05/2011SE |
| K102865 | DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound SystemITX · Special | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 11/03/2010SE |
| K102041 | AixplorerITX · Traditional | Supersonic Imagine | 10/13/2010SE |
| K101816 | STN ProbeITX · Special | Summit Doppler Systems, Inc. | 08/19/2010SE |
| K101757 | Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound SystemITX · Traditional | Sonosite,Inc. | 08/12/2010SE |
| K101829 | The Sonoace R3 Diagnostic Ultrasound SystemITX · Traditional | Medison Co., Ltd. | 07/16/2010SE |
| K101008 | Digital Color Doppler Ultrasound Imaging System, Convex Array Transducer, Linear ArrayITX · Traditional | Shantou Institute of Ultrasonic Instruments (Siui | 06/08/2010SE |
| K101041 | DC-7 Diagnostic Ultrasound SystemITX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/30/2010SE |
| K100204 | SonalisITX · Traditional | Smith Associates | 02/19/2010SE |
| K100067 | Model Viamo SSA-640A, Version 2.0 Ultrasound SystemITX · Traditional | Toshiba America Medical Systems, In.C | 01/28/2010SE |
| K093713 | Ultrasound General Purpose Guidance SystemITX · Traditional | Civco Medical Instruments | 01/19/2010SE |
| K093714 | Sonoace X8 Diagnostic Ultrasound SystemITX · Traditional | Medison Co., Ltd. | 12/10/2009SE |
| K093462 | Sonix Ultrasound ScannerITX · Traditional | Ultrasonix Medical Corporation | 11/20/2009SE |
| K092858 | Safersonic Sonography CoverITX · Traditional | Safersonic Medizinprodukte GmbH | 11/10/2009SE |
| K092691 | DC-7 Diagnostic Ultrasound SystemITX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 10/15/2009SE |
| K092756 | GE Vscan Compact Diagnostic Ultrasound SystemITX · Traditional | Ge Vingmed Ultrasound AS | 09/28/2009SE |
| K091828 | Sheathesiso Ultrasound Transducer CoverITX · Traditional | Sheathing Technologies, Inc. | 09/28/2009SE |
| K092637 | Pacscan Plus, Models 300P and 300APITX · Special | Sonomed, Inc. | 09/24/2009SE |
| K091877 | Chison Digital Color Doppler Ultrasound System, Convex Probe, Linear Probe, Phased Array…ITX · Traditional | Chison Medical Imaging Co., Ltd. | 09/02/2009SE |
| K091804 | CX50 Version 2.0 Diagnostic Ultrasound System and TransducersITX · Traditional | Philips Ultrasound, Inc. | 07/17/2009SE |
| K091941 | DC-3/DC-3T Diagnostic Ultrasound SystemITX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 07/09/2009SE |
| K091680 | Digital Ultrasonic Diagnostic Imaging SystemITX · Traditional | Edan Instruments, Inc. | 06/19/2009SE |
| K091295 | Aplio XG Diagnostic Ultrasound System Model SSA-790A Version 4.0ITX · Traditional | Toshiba America Medical Systems, In.C | 05/15/2009SE |
| K090912 | Digital Ultrasonic Diagnostic Imaging System, Model DP-6900ITX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/15/2009SE |
| K090465 | Digdop Ultrasound SystemITX · Traditional | The Newman Group, LLC | 04/08/2009SE |
| K083824 | Humanscan M5S-D Ultrasound TransducerITX · Traditional | Humanscan Company, Ltd. | 02/10/2009SE |
| K083667 | Needle Guide for 8814, Model UA1335, Needle Guide for 8815, Model Ua 1336, Needle Guide…ITX · Traditional | B-K Medical Aps | 02/02/2009SE |
| K083877 | Flying Diagnostic Ultrasound SystemITX · Traditional | Neusoft Medical Systems Co., Ltd. | 01/13/2009SE |
| K082224 | Diagnostic Ultrasound System Sarano, Echo View, ShimasonicITX · Traditional | Shimadzu Medical Systems | 12/15/2008SE |
| K082893 | Prager ShellITX · Traditional | Esi, Inc. | 12/05/2008SE |
| K081919 | UF-870 AG Diagnostic Ultrasound SystemITX · Special | Fukuda Denshi Co., Ltd. | 09/09/2008SE |
| K081802 | CX50 Diagnostic Ultrasound SystemITX · Traditional | Philips Ultrasound, Inc. | 07/11/2008SE |
| K080970 | Ushifu StepperITX · Traditional | Ushifu Development Company, LLC | 06/11/2008SE |
| K080555 | Sofia Automated Tomographic Ultrasound (Atus)ITX · Traditional | Ivu Imaging Corporation | 06/03/2008SE |
| K073623 | Atlantis 018 Peripheral Imaging CatheterITX · Traditional | Boston Scientific Corp | 03/13/2008SE |
| K080272 | Atlantis Pvimaging Catheter, Model H749364560ITX · Traditional | Boston Scientific Corp | 03/11/2008SE |
| K080119 | ClearscanITX · Traditional | Esi, Inc. | 02/21/2008SE |
| K071291 | Echoview / Shimasonic Diagnostic Ultrasound System, Model SDU-1100ITX · Traditional | Shimadzu Medical Systems | 01/09/2008SE |
| K071289 | Echoview / Shimasonic Diagnostic Ultrasound System, Model SDU-1200PROITX · Traditional | Shimadzu Medical Systems | 01/09/2008SE |
| K071287 | Echoview / Shimasonic Diagnostic Ultrasound Device, Model SDU-2200PROITX · Traditional | Shimadzu Medical Systems | 01/09/2008SE |
| K072786 | Acuson S2000 Ultrasound SystemITX · Traditional | Siemens Medical Solutions USA, Inc. | 11/13/2007SE |
| K072918 | Model SSA-680A Xario XG Diagnostic Ultrasound System, Version 1.00ITX · Traditional | Toshibamedical Systems Corporation | 10/29/2007SE |
| K072826 | Aplio Artida Diagnostic Ultrasound SystemITX · Traditional | Toshiba America Medical Systems, In.C | 10/24/2007SE |
| K070195 | Broadsound, AL3C34A,AL7L50A, AL3C79B,AL7L24B, AT3P42A, AT3C52B, ATL5L40B, AT3P32A, AT3C42BITX · Abbreviated | Broadsound Corporation | 10/15/2007SE |
| K072541 | Senosonix Ultrasound Breast Biopsy SystemITX · Traditional | Senorx, Inc. | 09/25/2007SE |
| K072164 | DC-6 Diagnostic Ultrasound SystemITX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 09/05/2007SE |
| K072285 | Aloka Ssd-Alpha 7 Ultrasound SystemITX · Traditional | Aloka Co., Ltd. | 08/30/2007SE |
| K072266 | Acuson P50 Diagnostic Ultrasound SystemITX · Traditional | Siemens Medical Solutions USA, Inc. | 08/29/2007SE |
| K070515 | A-View Basic and PlusITX · Traditional | Cordatec N.V. | 07/30/2007SE |
| K070903 | MYLAB40ITX · Traditional | Esaote Europe B.V. | 07/02/2007SE |
| K061153 | Gynesonics EC6 TransducerITX · Traditional | Gynesonics, Inc. | 10/27/2006SE |
| K061560 | SonomarkITX · Traditional | Medical Products Manufacturing, Inc. | 08/18/2006SE |
| K060947 | Sonicath Ultra Imaging Catheter, 3.2F,20MHZ Models 37410/456221/C1020ITX · Special | Boston Scientific Corp | 04/19/2006SE |
| K060879 | Model EC9-4 TransducerITX · Special | Siemens Medical Solutions USA, Inc. | 04/19/2006SE |
| K053463 | Aim Accuracy in Marking SystemITX · Traditional | Georgene Austria | 03/07/2006SE |
| K052517 | Site-Rite 5 Ultrasound SystemITX · Traditional | C.R. Bard, Inc. | 09/29/2005SE |
| K052021 | V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerITX · Special | Siemens Medical Solutions USA, Inc. | 08/17/2005SE |
| K050320 | Freescan Latex-Free Ultrasound Transducer Cover KitITX · Traditional | Ascendia Medtech AB | 08/15/2005SE |
| K050724 | Sure-Point Midline Stepping and Stabilization SystemITX · Special | C.R. Bard, Inc. | 04/18/2005SE |
| K043425 | Sheathes Needle Guide, Model NG-SR-A-484-KIT (There Will Be Various Model Numbers Based…ITX · Traditional | Sheathing Technologies, Inc. | 02/28/2005SE |
| K043278 | Teratech Model 8IOC4, 8IOL4 & 10LAP4 ProbesITX · Traditional | Teratech Corp. | 12/13/2004SE |
| K032315 | IOP8 Intra Operative ProbeITX · Traditional | Huntleigh Healthcare, Inc. | 11/18/2004SE |
| K041818 | Sonicath Ultra Imaging Catheter 3.2F 20MHZ, Models 37410/456221/C1020ITX · Special | Boston Scientific Corp | 11/10/2004SE |
| K042445 | Site-Rite Needle Guide Kits and Probe Cover KitITX · Traditional | Bard Access Systems, Inc. | 10/19/2004SE |
| K040213 | MHLX7EC TransducerITX · Traditional | Microhelix, Inc. | 09/22/2004SE |
| K041638 | Targetscan Biopsy KitITX · Traditional | Envisioneering, LLC | 09/02/2004SESK |
| K041637 | Targetscan Transrectal Ultrasound SystemITX · Traditional | Envisioneering, LLC | 09/01/2004SE |
| K041397 | EG-3830UTITX · Traditional | Pentax Precision Instrument Corp. | 06/09/2004SE |
| K041396 | FG-36UX Fiber Ultrasound GastroscopeITX · Traditional | Pentax Precision Instrument Corp. | 06/09/2004SE |
| K041395 | EG-3630URITX · Traditional | Pentax Precision Instrument Corp. | 06/09/2004SE |
| K040840 | Teratech Model 10V5 Smart ProbeITX · Traditional | Teratech Corp. | 04/14/2004SE |
| K022156 | Latex Ultrasonic Probe CoverITX · Abbreviated | Pleasure Latex Products Sdn. Bhd. | 09/11/2003SE |
| K031920 | Crosspoint Transaccess Catheter, Model TA-XP-001ITX · Special | Trans Vascular Incorporated | 07/23/2003SE |
| K030518 | Ameritek Sure-Point Tracker SystemITX · Traditional | Amertek Medical, Inc. | 05/20/2003SE |
| K031358 | Transvaginal Doppler ProbeITX · Traditional | Vascular Control Systems, Inc. | 05/09/2003SE |
| K030064 | Ilook 25 Needle Guide Attachment and Bracket AssemblyITX · Traditional | Sonosite,Inc. | 01/22/2003SE |
| K022860 | Atlantis PV Imaging Catheter, Model 36456ITX · Special | Boston Scientific, Target | 11/21/2002SE |
| K023024 | Transvaginal Doppler Probe, Model 09-0006-02ITX · Traditional | Vascular Control Systems, Inc. | 09/26/2002SE |
| K022649 | Cook-Swartz Doppler Flow ProbeITX · Special | Cook Vascular, Inc. | 09/06/2002SE |
| K013363 | Crosspoint Transaccess CatheterITX · Traditional | Trans Vascular Incorporated | 04/02/2002SE |
| K013723 | Modification to: EUB-6500 Diagnostic Ultrasound ScannerITX · Special | Hitachi Medical Corp. | 02/06/2002SE |
| K014182 | Tetrad Model TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TransducersITX · Traditional | Tetrad Corp. | 01/03/2002SE |
| K013721 | Synthetic Polysioprene Ultrasound Transducer CoverITX · Traditional | CIVCO Medical Instruments Co., Inc. | 12/28/2001SE |
| K002958 | Shapeable Doppler Flow ProbeITX · Traditional | Cook Vascular, Inc. | 12/18/2001SE |
| K013849 | Tetrad Model TC-EC7-ACP, -L5-, -L7-, -V4-ACP TransducersITX · Traditional | Tetrad Corp. | 12/03/2001SE |
| K013170 | Scantac Membrane or Scantac StripITX · Traditional | Sonotech, Inc. | 11/13/2001SE |
| K011265 | Ultrasound Transducer CoverITX · Traditional | Advance Medical Designs, Inc. | 10/30/2001SE |
| K012522 | Wavelength Multi-Purpose Ultrasound GelITX · Traditional | National Therapy Products, Inc. | 10/18/2001SE |
| K011581 | Ameritek Brachytherapy TemplateITX · Traditional | Amertek Medical, Inc. | 07/17/2001SE |
| K011284 | Thin Film Dressing for Ultrasound ExamITX · Traditional | Martin E. Wendelken | 06/20/2001SE |
| K011314 | Olympus GF UC140P-AL5 Ultrasonic Endoscope with Aloka SSD-5500 Ultrasound SystemITX · Traditional | Aloka Co., Ltd. | 05/15/2001SE |
| K002193 | Tetrad TC-C3-ACPITX · Traditional | Tetrad Corp. | 05/04/2001SE |
| K010883 | Teratech Model 8EC4 Endocavity Smart ProbeITX · Traditional | Teratech Corp. | 04/06/2001SE |
| K002856 | AT3C70 TransducerITX · Abbreviated | Sonora Medical Systems | 04/02/2001SE |
| K002784 | Aloka UST-5280-5ITX · Traditional | Aloka Co., Ltd. | 09/20/2000SE |
| K994103 | Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for…ITX · Traditional | Olympus America, Inc. | 09/05/2000SE |
| K994106 | Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Bronchial UseITX · Traditional | Olympus America, Inc. | 06/02/2000SE |
| K994069 | Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Urinary UseITX · Traditional | Olympus America, Inc. | 06/02/2000SE |
| K001203 | Olympus Um 2R/3R Ultrasonic Probe and Associated Ancillary Equipment for Female…ITX · Traditional | The Olympus Optical Co. | 05/26/2000SE |
| K992178 | Balloon for Ultrasonic EndoscopesITX · Traditional | N.M. Beale Co., Inc. | 05/12/2000SE |
| K001016 | GE Logiq 700ITX · Special | GE Medical Systems | 04/24/2000SE |
| K994373 | Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound Transducer…ITX · Traditional | Atl Ultrasound, Inc. | 03/24/2000SE |
| K992305 | Medi-Stim Butterfly Flowmeter, Model BF1000-BF2004ITX · Traditional | Medi-Stim A/S | 09/08/1999SE |
| K982208 | Irl Vasoscan(Tm) Intravascular Ultrasound CatheterITX · Traditional | Jomed Imaging , Ltd. | 08/27/1999SE |
| K992152 | General Purpose Transducer Standoff, Biopsy Transducer Standoff, Bi-Plane Endocavity…ITX · Traditional | CIVCO Medical Instruments Co., Inc. | 08/17/1999SE |
| K984639 | The S-Vna 5-8(B) Diagnostic Ultrasound TransducerITX · Traditional | Medison America, Inc. | 07/12/1999SE |
| K992155 | Volusion Small Parts Transducer, Model S-Vnw 5-10, Volusion Abdominal Transducer, Model…ITX · Traditional | Medison America, Inc. | 07/08/1999SE |
| K984562 | VivosonicITX · Traditional | Sonotech, Inc. | 06/08/1999SE |
| K991236 | General Purpose Neoflex Transducer Cover, Edocavity Neoflex Transducer Cover, Surgi-Tip…ITX · Traditional | CIVCO Medical Instruments Co., Inc. | 06/02/1999SE |
| K983691 | Scanflex Solid Couplant MembraneITX · Traditional | Sonotech, Inc. | 05/05/1999SE |
| K990175 | Sheathes (Non-Latex), SterileITX · Traditional | Sheathing Technologies, Inc. | 04/21/1999SE |
| K983985 | Hybrisonic SheathITX · Traditional | Sonotech, Inc. | 02/25/1999SE |
| K990400 | Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging SystemITX · Traditional | Hewlett-Packard Co. | 02/24/1999SE |
| K982568 | Bladdermanager Pci 5000 Model 1002ITX · Traditional | Diagnostic Ultrasound Corp. | 01/25/1999SE |
| K982329 | Visions 8.2F PV Ultrasonic Imaging Catheter (Model 88900)ITX · Traditional | Endosonics Corp. | 01/14/1999SE |
| K982323 | Olympus Um 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial UseITX · Traditional | Olympus America, Inc. | 12/11/1998SE |
| K982610 | Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)ITX · Traditional | Olympus Optical, Co. | 11/16/1998SE |
| K982733 | Olympus MH-246R Balloon Sheath, for Bronchial UseITX · Traditional | The Olympus Optical Co. | 10/28/1998SE |
| K982725 | Olympus MH-246R Balloon Sheath, for Female Reproductive Tract UseITX · Traditional | Olympus America, Inc. | 10/23/1998SE |
| K981069 | Ultra-Cover Pu-Transducer CoverITX · Traditional | International Medical Products B.V. | 09/23/1998SE |
| K981028 | Ultra Image and Ultra ScanITX · Traditional | Sonotech, Inc. | 08/21/1998SE |
| K981434 | EUP-OL334 LaparascopicprobeITX · Traditional | Hitachi Medical Corp. of America | 07/27/1998SE |
| K964001 | Swartz Doppler Flow Probe and Monitor SystemITX · Traditional | Med Institute, Inc. | 04/17/1998SE |
| K980091 | Lubriscan Ultra Scan Gel +, Model RG2-60ITX · Traditional | Cosmaceutical Marketing, Inc. | 04/09/1998SE |
| K974544 | ASU-1000 Diagnostic Ultrasound TransducerITX · Traditional | Aloka Co., Ltd. | 03/18/1998SE |
| K972771 | Phased Array Transducer - - PVF -375DTITX · Traditional | Toshiba America Medical Systems, In.C | 02/11/1998SE |
| K974301 | CLK Int'L. Sanitary Latex Probe Cover, CLK Ultrasound Probe CoverITX · Traditional | Clk Intl., Inc. | 02/06/1998SE |
| K973713 | 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D.…ITX · Traditional | Cardiovascular Dynamics, Inc. | 01/23/1998SE |
| K973958 | General Purpose Atl Needle Guide KitITX · Traditional | Protek Medical Products, Inc. | 01/22/1998SE |
| K971116 | Sonos 5500 Imaging SystemITX · Traditional | Hewlett-Packard Co. | 01/12/1998SE |
| K955893 | Everytime Transfucer CoverITX · Traditional | Amedic AB | 12/30/1997SE |
| K973622 | Transducer PositionerITX · Traditional | Protek Medical Products, Inc. | 11/26/1997SE |
| K973079 | L7 Transducer Used on Aspen Model Ultrasound SystemITX · Traditional | Acuson Corp. | 11/05/1997SE |
| K973362 | Needle Guide/GridITX · Traditional | Protek Medical Products, Inc. | 10/01/1997SE |
| K971397 | Viewcath 3-D Catheter PullbackITX · Traditional | Quinton, Inc. | 08/25/1997SE |
| K972152 | Devmed Stepping and Stabilizing SystemITX · Traditional | Devmed Corp. | 08/15/1997SE |
| K955668 | Intracavity Needle Guide KitITX · Traditional | Arlanda Medicinska Instrument Co. AB | 07/30/1997SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1006-2026 Class II | Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm…Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in… | Sheathing Technologies Inc | 11/17/2025Open, Classified |
| Z-1628-2026 Class III | Philips X7-2 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 09/05/2025Open, Classified |
| Z-1627-2026 Class III | Philips X3-1 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 09/05/2025Open, Classified |
| Z-1626-2026 Class III | Philips S5-2 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 09/05/2025Open, Classified |
| Z-1625-2026 Class III | Philips S4-1 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 09/05/2025Open, Classified |
| Z-1624-2026 Class III | Philips OMNI III TEE Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 09/05/2025Open, Classified |
| Z-1623-2026 Class III | Philips OMNI II TEE Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 09/05/2025Open, Classified |
| Z-1622-2026 Class III | Philips Mini Multi TEE Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 09/05/2025Open, Classified |
| Z-1621-2026 Class III | Philips L17-5 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 09/05/2025Open, Classified |
| Z-1620-2026 Class III | Philips L12-5 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 09/05/2025Open, Classified |
| Z-1619-2026 Class III | Philips C9-4 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 09/05/2025Open, Classified |
| Z-1618-2026 Class III | Philips 3D6-2 Ultrasound TransducerTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 09/05/2025Open, Classified |
| Z-0038-2026 Class II | ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE…Production assembly error resulting in the potential for reversed articulation, where moving the lever… | ImaCor Inc. | 08/29/2025Open, Classified |
| Z-2400-2025 Class III | SCNHD LA L7-4 HDI Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2348-2025 Class III | 7.5MHZ Endo Transducer ProbeTo provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Philips Ultrasound, Inc | 07/03/2025Open, Classified |
| Z-2068-2025 Class II | Philips XL14-3 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2067-2025 Class II | Philips X8-2t Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2066-2025 Class II | Philips X7-2t Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2065-2025 Class II | Philips X6-1 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2064-2025 Class II | Philips X5-1 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2063-2025 Class II | Philips VL13-5 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2062-2025 Class II | Philips V6-2 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2061-2025 Class II | Philips S8-3t Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2060-2025 Class II | Philips S7-3t Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2059-2025 Class II | Philips S7-2 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2058-2025 Class II | Philips S5-1 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2057-2025 Class II | Philips L9-3 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2056-2025 Class II | Philips L8-4 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2055-2025 Class II | Philips L12-4 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2054-2025 Class II | Philips L12-3 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2053-2025 Class II | Philips eL18-4 EMT Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2052-2025 Class II | Philips eL18-4 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2051-2025 Class II | Philips C9-5EC Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2050-2025 Class II | Philips C5-2 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2049-2025 Class II | Philips C5-1 Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-2048-2025 Class II | Philips 3D9-3v Transducer.Ultrasound transducer devices were refurbished beyond their useful life. | Philips Ultrasound, Inc | 05/28/2025Open, Classified |
| Z-1892-2025 Class II | BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter)…During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle… | Civco Medical Instruments Co. Inc. | 05/01/2025Open, Classified |
| Z-1490-2026 Class II | Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid… | Esaote S.P.A. | 03/14/2025Completed |
| Z-0231-2025 Class II | ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor…Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could… | ImaCor Inc. | 09/16/2024Open, Classified |
| Z-0333-2024 Class II | Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for…Channel air drying process was not validated, and that a small percentage of scopes returned to customers… | Aizu Olympus Co., Ltd. | 09/25/2023Open, Classified |
| Z-2535-2023 Class II | Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b)…Ultrasound gel mislabeled with inappropriate use. | Advance Medical Designs, Inc. | 07/07/2023Open, Classified |
| Z-2534-2023 Class II | Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b)…Ultrasound gel mislabeled with inappropriate use. | Advance Medical Designs, Inc. | 07/07/2023Open, Classified |
| Z-2517-2023 Class II | 3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50…Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come… | Philips Ultrasound, Inc. | 06/30/2023Completed |
| Z-0759-2023 Class II | Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in…Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they… | GE Medical Systems, LLC | 11/10/2022Open, Classified |
| Z-0758-2023 Class II | Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in…Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they… | GE Medical Systems, LLC | 11/10/2022Open, Classified |
| Z-0757-2023 Class II | Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics…Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they… | GE Medical Systems, LLC | 11/10/2022Open, Classified |
| Z-0756-2023 Class II | Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525…Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they… | GE Medical Systems, LLC | 11/10/2022Open, Classified |
| Z-1034-2022 Class II | Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound…GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection… | Olympus Corporation of the Americas | 03/18/2022Open, Classified |
| Z-0960-2022 Class II | HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10…Faceplate may become detached from the probe body. | Huntleigh Healthcare Ltd. | 02/11/2022Terminated |
| Z-0194-2022 Class I | IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L…Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial… | Lumenis, Inc. | 10/14/2021Terminated |