System, Imaging, Pulsed Echo, Ultrasonic
FDA product code IYO · Class II (moderate risk) · 21 CFR 892.1560 · Radiology
894510(k) clearances
0PMA approvals
82recalls
Manufacturers
- Siemens Medical Solutions USA, Inc. 31
- General Electric Co. 21
- Advanced Technology Laboratories, Inc. 20
- Volcano Corporation 19
- Hewlett-Packard Co. 14
- Ausonics Pty , Ltd. 12
- Toshiba Medical Systems 12
- Hitachi Medical Corp. of America 12
- Echosens 11
- GE Medical Systems, LLC 11
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 11
- Diasonics, Inc. 10
- Medison America, Inc. 10
- Acuson Corp. 10
- Elscint, Inc. 10
- Toshiba America Medical Systems, In.C 9
- Teknar, Inc. 9
- Technicare Corp. 8
- Aloka Co., Ltd. 8
- Quantel Medical 8
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253452 | Accuro 3SIYO · Traditional | Rivanna Medical, Inc. | 07/24/2026SE |
| K260190 | ArthurIYO · Traditional | ROPCA ApS | 06/18/2026SE |
| K252237 | EdgeFlow UW20IYO · Traditional | Edgecare, Inc. | 04/17/2026SE |
| K254021 | Accuro XVIYO · Traditional | Rivanna Medical, Inc. | 04/09/2026SE |
| K253898 | QT Scanner 2000 Model AIYO · Special | QT Imaging Holdings, Inc. | 03/04/2026SE |
| K253714 | IntraSight PlusIYO · Traditional | Philips Image Guided Therapy Corporation | 02/24/2026SE |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)IYO · Traditional | Eieling Technology (Shenzhen) Limited | 02/06/2026SE |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro)IYO · Traditional | Astrasono Technology Co., Ltd. | 09/30/2025SE |
| K250381 | Deepsight NeedleVue LC1 Ultrasound SystemIYO · Traditional | DeepSight Technology, Inc. | 08/01/2025SE |
| K243227 | B-ScanIYO · Traditional | Accutome, Inc. Doing Business AS Keeler USA | 07/11/2025SE |
| K251728 | Velacur One (LI-1100)IYO · Special | Sonic Incytes Medical Corp | 06/26/2025SE |
| K243880 | Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800…IYO · Traditional | Wuxi Hisky Medical Technologies Co., Ltd. | 06/17/2025SE |
| K243937 | Accuro 3SIYO · Traditional | Rivanna Medical, Inc. | 05/23/2025SE |
| K243479 | EchoGuide (Version 1)IYO · Traditional | Sonavex, Inc. | 04/23/2025SE |
| K242496 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)IYO · Traditional | Eieling Technology (Shenzhen) Limited | 11/19/2024SE |
| K241029 | SpineUs SystemIYO · Traditional | Verdure Imaging | 10/07/2024SE |
| K233977 | VelacurIYO · Traditional | Sonic Incytes | 09/04/2024SE |
| K233579 | SC1 Handheld Ultrasound Imaging system (Model: SC1)IYO · Special | Fcu Co., Ltd. | 06/26/2024SE |
| K233613 | ACUSON SC2000 Diagnostic Ultrasound SystemIYO · Special | Siemens Medical Solutions USA, Inc. | 06/12/2024SE |
| K232895 | B-Ultrasound Diagnostic SystemIYO · Traditional | Contec Medical Systems Co.,Ltd | 05/03/2024SE |
| K232302 | Pocket IIIIYO · Traditional | Quantel Medical | 04/26/2024SE |
| K231677 | EdgeFlow UH10IYO · Traditional | Edgecare, Inc. | 03/06/2024SE |
| K240146 | BD Prevue II Peripheral Vascular Access SystemIYO · Special | Bard Access Systems, Inc. | 02/18/2024SE |
| K233401 | Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)IYO · Traditional | Eieling Technology Limited | 02/12/2024SE |
| K230986 | Bladder ScannerIYO · Traditional | Avantsonic Technology Co., Ltd. | 12/29/2023SE |
| K232320 | iSR`obot Mona Lisa 2.0IYO · Special | Biobot Surgical Pte., Ltd. | 12/21/2023SE |
| K231889 | Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic…IYO · Traditional | Ultrasound Biotechnology (Shanghai) Co., Ltd. | 12/21/2023SE |
| K230511 | K3900 Ultrasound Imaging SystemIYO · Traditional | Maui Imaging | 10/25/2023SE |
| K232459 | VelacurIYO · Special | Sonic Incytes | 09/12/2023SE |
| K231283 | SiteRite 9 Ultrasound SystemIYO · Traditional | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 09/11/2023SE |
| K223448 | Bladder Scanner Model: BVT02IYO · Traditional | Xuzhou Kaixin Electronic Instrument Co., Ltd. | 07/07/2023SE |
| K223287 | VelacurIYO · Traditional | Sonic Incytes | 04/20/2023SE |
| K220068 | Butterfly iQ/iQ+ Ultrasound SystemIYO · Traditional | Butterfly Network, Inc. | 03/31/2023SE |
| K223902 | FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630)IYO · Traditional | Echosens | 03/02/2023SE |
| K222787 | Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C…IYO · Traditional | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 01/09/2023SE |
| K220933 | QT Scanner 2000 Model AIYO · Traditional | Qt Imaging, Inc. | 08/31/2022SE |
| K213488 | Bladder Scanner, Model Name:M5IYO · Traditional | Suzhou Peaksonic Medical Technology Co., Ltd. | 07/01/2022SE |
| K211529 | NAVIRFA ScopeIYO · Traditional | Navifus Corporation | 05/05/2022SE |
| K213620 | ATUSA Automated 3D Breast Ultrasound SystemIYO · Traditional | Isono Health, Inc. | 04/22/2022SE |
| K212851 | EchoSK and EchoSGyn modules for EchoS Family devicesIYO · Traditional | Echolight S.P.A | 03/16/2022SE |
| K213411 | iSRobot Mona Lisa 2.0IYO · Traditional | Biobot Surgical Pte., Ltd. | 12/22/2021SE |
| K213303 | Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging…IYO · Traditional | Infraredx, Inc. | 12/07/2021SE |
| K213070 | MD-320W Ultrasound BiomicroscopeIYO · Traditional | MEDA Co., Ltd. | 11/18/2021SE |
| K213254 | Axialis Ophthalmic Ultrasound SystemIYO · Traditional | Quantel Medical | 11/15/2021SE |
| K211726 | Acuson SC2000 Diagnostic Ultrasound SystemIYO · Traditional | Siemens Medical Solutions USA, Inc. | 11/05/2021SE |
| K212035 | FibroScan 230IYO · Special | Echosens | 07/30/2021SE |
| K210468 | SC1 Handheld Ultrasound Imaging System (Model: SC1)IYO · Traditional | Fcu Co., Ltd. | 07/23/2021SE |
| K203659 | iSR'obot Mona Lisa 1.0IYO · Traditional | Biobot Surgical Pte., Ltd. | 07/08/2021SE |
| K211193 | BD Prevue II Peripheral Vascular Vascular Access SystemIYO · Traditional | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 06/25/2021SE |
| K211623 | THD Procto Software SystemIYO · Special | Thd Spa | 06/24/2021SE |
| K210591 | Palm Bladder Scanner - PBSV7.1IYO · Special | Mianyang Meike Electronic Equipment Co., Ltd. | 06/09/2021SE |
| K211098 | Breast Volume Navigator (BVN) Model G-2000IYO · Traditional | Metritrack, Inc. | 05/26/2021SE |
| K203273 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)IYO · Traditional | Echosens | 03/25/2021SE |
| K201316 | Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)IYO · Traditional | Suzhou Peaksonic Medical Technology Co., Ltd. | 02/26/2021SE |
| K203719 | IntraSight MobileIYO · Special | Volcano Corporation | 01/19/2021SE |
| K202119 | AcuSee AS-P1000 SystemIYO · Traditional | Weipeng (Suzhou) Medical Devices Co., Ltd. | 10/07/2020SE |
| K201995 | CUBEScan BioCon-1100IYO · Special | Mcube Technology Co., Ltd. | 08/19/2020SE |
| K201597 | Liver Incytes, Model 1005IYO · Traditional | Sonic Incytes | 07/31/2020SE |
| K200655 | FibroScan® 630IYO · Traditional | Echosens | 07/16/2020SE |
| K200980 | Auto 3D Bladder Volume ToolIYO · Traditional | Butterfly Network, Inc. | 06/11/2020SE |
| K200749 | CUBEScan BioCon-900SIYO · Traditional | Mcube Technology Co., Ltd. | 05/19/2020SE |
| K200548 | CUBEScan BioCon-1100IYO · Traditional | Mcube Technology Co., Ltd. | 03/27/2020SE |
| K200136 | Shear Wave Quantificational Ultrasound Diagnostic SystemIYO · Traditional | Wuxi Hisky Medical Technologies Co., Ltd. | 03/17/2020SE |
| K192253 | SonicEye Dual-Array Ultrasound SystemIYO · Traditional | Sonivate Medical, Inc. | 02/25/2020SE |
| K193512 | THD Procto Software SystemIYO · Traditional | Thd Spa | 01/26/2020SE |
| K192170 | VistaScan USB Ultrasound Imaging SystemIYO · Traditional | Emagine Solutions Technology, LLC | 01/23/2020SE |
| K192791 | Diagnostic Ultrasound SystemIYO · Traditional | Edan Instruments, Inc. | 11/27/2019SE |
| K192573 | Dolphin Medical Imaging USB Ultrasound SystemIYO · Traditional | Dolphin Medical Imaging, LLC | 11/19/2019SE |
| K190646 | QT Scanner 2000 Model AIYO · Traditional | Qt Ultrasound, LLC | 10/18/2019SE |
| K190314 | Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000IYO · Traditional | Mednovel Technology, Ltd. | 10/09/2019SE |
| K191541 | Vave Personal Ultrasound SystemIYO · Traditional | Vave Health, Inc. | 07/10/2019SE |
| K183173 | LIGHTMED Ultrasound SystemIYO · Traditional | Lightmed USA, Inc. | 07/01/2019SE |
| K191307 | Palm Bladder Scanner - PBSV5.1IYO · Special | Mianyang Meike Electronic Equipment Co., Ltd. | 06/05/2019SE |
| K190769 | Bladder Scanner (Models: M2, M2-W, M1, M1-W)IYO · Traditional | Suzhou Lischka Medtech Co., Ltd. | 05/22/2019SE |
| K182460 | MD-6000P Bladder ScannerIYO · Traditional | MEDA Co., Ltd. | 05/06/2019SE |
| K190786 | Eye PrimeIYO · Traditional | Ellex Medical Pty, Ltd. | 04/11/2019SE |
| K190186 | Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound SystemIYO · Traditional | Edan Instruments, Inc. | 03/28/2019SE |
| K183414 | AbsoluIYO · Traditional | Quantel Medical | 03/20/2019SE |
| K190039 | EchoSure Diagnostic Ultrasound SystemIYO · Traditional | Sonavex, Inc. | 03/08/2019SE |
| K182281 | Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechIYO · Traditional | C. R. Bard | 10/24/2018SE |
| K182213 | QT Ultrasound Breast Scanner - 1IYO · Special | Qt Ultrasound, LLC | 09/14/2018SE |
| K182153 | Ultrasound System SONIMAGE HS1IYO · Special | Konica Minolta, Inc. | 09/06/2018SE |
| K181574 | UscanIYO · Traditional | EchoNous, Inc. | 07/10/2018SE |
| K181547 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)IYO · Special | Echosens | 07/09/2018SE |
| K173595 | Shear Wave Quantificational Ultrasound Diagnostic SystemIYO · Traditional | Wuxi Hisky Medical Technologies Co., Ltd. | 06/22/2018SE |
| K180636 | ExactVu High Resolution Micro-Ultrasound SystemIYO · Traditional | Exact Imaging, Inc. | 04/30/2018SE |
| K170761 | LIGHTSonic BUBMIYO · Traditional | Lightmed USA, Inc. | 04/13/2018SE |
| K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…IYO · Traditional | Volcano Corporation | 04/11/2018SE |
| K180265 | COMPACT TOUCH Ophthalmic Ultrasound SystemIYO · Traditional | Quantel Medical | 03/02/2018SE |
| K172256 | SoftVueIYO · Traditional | Delphinus Medical Technologies | 03/02/2018SE |
| K172750 | Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe)IYO · Abbreviated | Guangzhou Sonostar Technologies Co., Ltd. | 02/28/2018SE |
| K180084 | Ultrasound System SONIMAGE MX1IYO · Traditional | Konica Minolta, Inc. | 02/08/2018SE |
| K171528 | Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5)IYO · Traditional | Avantsonic Technology Co., Ltd. | 01/24/2018SE |
| K172056 | InnoSight Diagnostic Ultrasound SystemIYO · Traditional | Qisda Corporation | 12/13/2017SE |
| K170046 | Lilium a-200EIYO · Traditional | Lilium Otsuka Co., Ltd. | 12/07/2017SE |
| K172931 | DUS-6000 Digital Ultrasonic Diagnostic Imaging SystemIYO · Abbreviated | Advanced Instrumentations, Inc. | 12/01/2017SE |
| K170856 | CMS600P2 B-Ultrasound Diagnostic SystemIYO · Traditional | Contec Medical Systems Co.,Ltd | 11/17/2017SE |
| K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)IYO · Traditional | Echosens | 11/14/2017SE |
| K173138 | Biim Diagnostic Ultrasound SystemIYO · Traditional | Biim Ultrasound AS | 10/27/2017SE |
| K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…IYO · Special | Volcano Corporation | 10/25/2017SE |
| K171594 | AccuroIYO · Traditional | Rivanna Medical, LLC | 10/20/2017SE |
| K171309 | BR-FHUS Navigation 1.0IYO · Traditional | Taihao Medical, Inc. | 09/29/2017SE |
| K172356 | BladderScan Prime PLUS SystemIYO · Traditional | Verathon Incorporated | 09/15/2017SE |
| K172142 | FibroScan 430 Mini+IYO · Traditional | Echosens | 09/13/2017SE |
| K171301 | Scanmate FlexIYO · Traditional | Dgh Technology, Inc. | 07/31/2017SE |
| K171824 | Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound SystemIYO · Traditional | Edan Instruments, Inc. | 07/18/2017SE |
| K171766 | Acuson SC2000 Diagnostic Ultrasound SystemIYO · Traditional | Siemens Medi Cal Solutions, Inc. | 07/12/2017SE |
| K171591 | CUBEScan BioCon-900 (Bladder Volume Measurement System)IYO · Traditional | Mcube Technology Co., Ltd. | 06/22/2017SE |
| K161354 | MELODY, Remote Control System for Ultrasound ProbeIYO · Traditional | Adecho Tech | 06/12/2017SE |
| K162372 | QT Ultrasound Breast Scanner-1IYO · Traditional | Qt Ultrasound, LLC | 06/06/2017SE |
| K170133 | FFR V2.5IYO · Traditional | Philips Volcano | 05/26/2017SE |
| K170385 | CORE M2 Vascular SystemIYO · Special | Volcano Corporation | 04/06/2017SE |
| K162972 | ExactVu High Resolution Micro-Ultrasound SystemIYO · Traditional | Exact Imaging | 12/02/2016SE |
| K161968 | MicrUsIYO · Traditional | Telemed | 11/03/2016SE |
| K161342 | Sonic WindowIYO · Special | Analogic Corporation | 06/15/2016SE |
| K161300 | Acclarix AX8 Diagnostic Ultrasound SystemIYO · Special | Edan Instruments, Inc. | 05/31/2016SE |
| K153620 | Enovare Ultrasound SystemIYO · Traditional | Oreon Technologies, Inc. | 05/05/2016SE |
| K160792 | Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundIYO · Traditional | The Prometheus Group | 04/15/2016SE |
| K153581 | Bladder ScannerIYO · Traditional | Caresono Technology Co., Ltd. | 04/08/2016SE |
| K160420 | SpeqTIYO · Traditional | Signostics Limited | 03/21/2016SE |
| K160524 | FibroScan 530 CompactIYO · Special | Echosens | 03/18/2016SE |
| K153416 | ArcScan Insight 100IYO · Special | Arcscan, Inc. | 02/02/2016SE |
| K153369 | SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5izIYO · Special | Volcano Corporation | 12/22/2015SE |
| K152554 | Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyIYO · Traditional | C.R. Bard, Inc. | 12/14/2015SE |
| K152573 | 4SightIYO · Traditional | Accutome, Inc. | 11/25/2015SE |
| K153101 | BladderScan Prime SystemIYO · Traditional | Verathon Incorporated | 11/19/2015SE |
| K152318 | MD-2300S Ultrasonic A/B Scanner for OphthalmologyIYO · Traditional | MEDA Co., Ltd. | 11/17/2015SE |
| K152316 | iLab Ultrasound Imaging SystemIYO · Special | Boston Scientific | 09/18/2015SE |
| K151339 | SONON Ultrasound Imaging System (Model: SONON 300C)IYO · Traditional | Healcerion Co., Ltd. | 09/10/2015SE |
| K150239 | FibroScanIYO · Traditional | Echosens | 09/01/2015SE |
| K151709 | Hi-Light Diagnostic Ultrasound SystemsIYO · Traditional | Qingdao Hisense Medical Equipment Co., Ltd. | 07/17/2015SE |
| K151060 | Ultrasound System SONIMAGE HS1IYO · Traditional | Konica Minolta, Inc. | 06/05/2015SE |
| K150949 | FibroScanIYO · Traditional | Echosens | 06/03/2015SE |
| K150342 | Touch UltrasoundIYO · Traditional | Carestream Health, Inc. | 05/08/2015SE |
| K150999 | Acclarix Diagnostic Ultrasound SystemIYO · Traditional | Edan Instruments, Inc. | 05/06/2015SE |
| K150580 | UltraVision 2 Diagnostic Ultrasound SystemIYO · Traditional | Winprobe Corporation | 04/07/2015SE |
| K150529 | Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound SystemIYO · Special | C.R. Bard, Inc. | 03/30/2015SE |
| K150441 | Volcano iFR Modality, iFR Scout featureIYO · Special | Volcano Corporation | 03/20/2015SE |
| K143122 | Volcano iFR Harvest Software (Offline)IYO · Special | Volcano Corporation | 02/20/2015SE |
| K143396 | omni TRAX Active Patient TrackerIYO · Traditional | Civco Medical Instruments CO Inc Dba Civco… | 01/23/2015SE |
| K143493 | SignosRT Bladder Ultrasound SystemIYO · Traditional | Signostics, Ltd. | 01/14/2015SE |
| K142329 | BBS RevolutionIYO · Abbreviated | Dbmedx, Inc. | 12/15/2014SE |
| K142517 | SoftVueIYO · Traditional | Delphinus Medical Technologies, Inc. | 10/31/2014SE |
| K142443 | Site-Rite 6 Ultrasound System with Pinpoint GT TechnologyIYO · Traditional | C.R. Bard, Inc. | 10/30/2014SE |
| K142054 | Imacor Zura Evo Imaging SystemIYO · Traditional | Imacor, Inc. | 09/29/2014SE |
| K141806 | Clear Guide OneIYO · Traditional | Clear Guide Medical | 09/19/2014SE |
| K142395 | SC2000 and ACUSON X300 Diagnostic Ultrasound SystemsIYO · Traditional | Siemens Medical Solutions USA, Inc. | 09/09/2014SE |
| K140428 | Ultrasound Scanner System BK2300IYO · Abbreviated | B-K Medical Aps | 05/30/2014SE |
| K140899 | Halo Medical Technologies Catalyst Midcrystl Halo Ultrasound SystemIYO · Traditional | Halo Medical Technologies, LLC | 05/05/2014SE |
| K140199 | VupadIYO · Traditional | Sonomed, Inc. | 04/01/2014SE |
| K133323 | Volcano Ifr ModalityIYO · Traditional | Volcano Corporation | 03/14/2014SE |
| K132736 | Accuro 3000 Ultrasound ScannerIYO · Traditional | Rivanna Medical, LLC | 03/11/2014SE |
| K140291 | Volcano Core Control Pad, Accessory to the Volcano S5/S5I Intravascular Ultrasound…IYO · Special | Volcano Corporation | 03/07/2014SE |
| K140126 | Sonic WindowIYO · Abbreviated | Analogic Corporation | 03/04/2014SE |
| K132346 | Ultrasound Scanner Pro Focus 2202IYO · Traditional | B-K Medical Aps | 01/10/2014SE |
| K133641 | Core Control Pad, Core Series SW V3.4 Installation Kit, Core, Core MobileIYO · Special | Volcano Corporation | 12/20/2013SE |
| K123209 | SoftvueIYO · Traditional | Delphinus Medical Technologies, Inc. | 12/19/2013SE |
| K133142 | Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option for…IYO · Special | Volcano Corporation | 11/15/2013SE |
| K132654 | Acuson SC2000 Diagnostic Ultrasound SystemIYO · Traditional | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 09/26/2013SE |
| K131830 | Digital Ultrasonic Diagnostic Imaging SystemIYO · Traditional | Edan Instruments, Inc. | 09/17/2013SE |
| K132228 | Ugeo PT60A Diagnostic Ultrasound SystemIYO · Traditional | Samsung Medison Co., Ltd. | 08/20/2013SE |
| K131690 | M7/M7T Diagnostic Ultrasound SystemIYO · Special | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 07/24/2013SE |
| K131227 | Padscan HD Series Bladder ScannerIYO · Traditional | Carenoso Technology Co., Ltd. | 07/12/2013SE |
| K131489 | Tractus Tissuemapper Image Recording System ApplicationIYO · Traditional | Tractus Corporation | 06/25/2013SE |
| K130944 | Isr'Obot Mona LisaIYO · Special | Biobot Surgical Pte., Ltd. | 06/07/2013SE |
| K121243 | Ultrasonic Biometer for Ophthalmology Ultrasonic PachymeterIYO · Traditional | MEDA Co., Ltd. | 05/03/2013SE |
| K123806 | FibroscanIYO · Traditional | Echosens | 04/05/2013SE |
| K130229 | Palm Bladder ScannerIYO · Abbreviated | Mianyang Meike Electronic Equipment Co., Ltd. | 03/20/2013SE |
| K130243 | Ilab Ultrasound Imaging SystemIYO · Special | Boston Scientific Corp | 03/01/2013SE |
| K123349 | A-Scan Plus ConnectIYO · Special | Accutome, Inc. | 01/29/2013SE |
| K123535 | Ilab Ultrasound Imaging SystemIYO · Special | Boston Scientific Corp | 01/15/2013SE |
| K123898 | Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemIYO · Special | Volcano Corporation | 01/14/2013SE |
| K123616 | Portable Ultrasonic Diagnostic SystemIYO · Special | Sonoscape Company Limited | 12/21/2012SE |
| K123185 | DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S Diagnostic Ultrasound SystemIYO · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 11/02/2012SE |
| K122574 | Digital Ultrasonic Diagnostic Imaging System, Model D3 and D6IYO · Traditional | Edan Instruments, Inc. | 10/12/2012SE |
| K121689 | Vitascan LT ScanmasterIYO · Traditional | Vitacon Medical, Inc. | 09/19/2012SE |
| K121479 | AimIYO · Traditional | Inneroptic Technology, Inc. | 09/13/2012SE |
| K121422 | Aplio 500/400/300 Diagnostic Ultrasound SystemIYO · Special | Toshiba Medical Systems Coporation, Japan | 08/16/2012SE |
| K121888 | E-Cube 15IYO · Traditional | Alpinion Medical Systems Co., Ltd. | 07/26/2012SE |
| K111818 | Sonixgps Needle SensorIYO · Traditional | Ultrasonix Medical Corporation | 06/13/2012SE |
| K121381 | Viewflex Xtra Ice CatheterIYO · Special | St Jude Medical | 06/07/2012SE |
| K120882 | Site Rite Prevue Ultrasound System and Pinpoint Needle GuideIYO · Traditional | Bard Access Systems, Inc. | 05/30/2012SE |
| K120201 | GE Vivid E9 Diagnostic Ultrasound Imaging SystemIYO · Traditional | Ge Vingmed Ultrasound AS | 04/19/2012SE |
| K113304 | Bladder ScannerIYO · Traditional | MEDA Co., Ltd. | 03/23/2012SE |
| K112539 | Chison Digital Ultrasound System, Convex Probe, Linear Probe, Transvaginal Micro-Convex…IYO · Traditional | Leiker Regulatory & Quality Consulting | 01/30/2012SE |
| K113486 | Volcano S5I Intravascular Ultracound Imaging and Pressure SystemIYO · Special | Volcano Corporation | 01/27/2012SE |
| K113632 | DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic…IYO · Special | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 01/25/2012SE |
| K113680 | Soma Access Systems Exacttrack Procedure KitIYO · Traditional | Soma Access Systems, LLC | 12/29/2011SE |
| K113153 | DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging SystemIYO · Special | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 11/28/2011SE |
| K113156 | Sonosite Edge Ultrasound SystemIYO · Traditional | Sonosite,Inc. | 11/15/2011SE |
| K112022 | DUS-3000/DUS-3000PLUS Digital Ultrasonic Diagnostic Imaging SystemIYO · Traditional | Advanced Instrumentations, Inc. | 09/22/2011SE |
| K111347 | Isrobot Mona LisaIYO · Traditional | Biobot Surgical Pte., Ltd. | 08/12/2011SE |
| K111706 | Volcano S5IINTRAVASCULAR Imaging and Pressure SystemIYO · Special | Volcano Corporation | 07/15/2011SE |
| K111435 | DP-50 Digital Ultrasonic Diagnostic Imaging SystemIYO · Special | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 07/08/2011SE |
| K110688 | MylabgoldIYO · Traditional | Esaote | 06/02/2011SE |
| K102253 | Echo BlasterIYO · Traditional | Telemed | 03/14/2011SE |
| K103148 | Aida Diagnostic Ultrasound SystemIYO · Traditional | Panasonic Healthcare Co., Ltd. | 03/11/2011SE |
| K102153 | Mobius Ultrasound Imaging SystemIYO · Traditional | Mobisante, Inc. | 01/20/2011SE |
| K103608 | I3 System-Abd Diagnostic UltrasoundIYO · Special | Ellex, Inc. | 12/27/2010SE |
| K102027 | Axis Nano Opthalmic Biometer Ultrasound SystemIYO · Traditional | Quantel Medical S.A. | 12/22/2010SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1738-2026 Class II | eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result… | Civco Medical Instruments Co. Inc. | 03/02/2026Open, Classified |
| Z-1737-2026 Class II | eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result… | Civco Medical Instruments Co. Inc. | 03/02/2026Open, Classified |
| Z-1736-2026 Class II | eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result… | Civco Medical Instruments Co. Inc. | 03/02/2026Open, Classified |
| Z-1735-2026 Class II | eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result… | Civco Medical Instruments Co. Inc. | 03/02/2026Open, Classified |
| Z-1734-2026 Class II | eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result… | Civco Medical Instruments Co. Inc. | 03/02/2026Open, Classified |
| Z-1733-2026 Class II | eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result… | Civco Medical Instruments Co. Inc. | 03/02/2026Open, Classified |
| Z-1732-2026 Class II | eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result… | Civco Medical Instruments Co. Inc. | 03/02/2026Open, Classified |
| Z-1731-2026 Class II | eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result… | Civco Medical Instruments Co. Inc. | 03/02/2026Open, Classified |
| Z-0901-2022 Class III | IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 300002018102Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of… | Volcano Corp | 01/24/2022Open, Classified |
| Z-0524-2022 Class II | GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the… | GE Healthcare, LLC | 11/04/2021Open, Classified |
| Z-0523-2022 Class II | GE Vscan Extend, being sold as "Vscan Extend Sector USB"The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the… | GE Healthcare, LLC | 11/04/2021Open, Classified |
| Z-0522-2022 Class II | GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the… | GE Healthcare, LLC | 11/04/2021Open, Classified |
| Z-0521-2022 Class II | GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the… | GE Healthcare, LLC | 11/04/2021Open, Classified |
| Z-0520-2022 Class II | GE Vscan Extend, being sold as "Vscan Extend Dual USB"The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the… | GE Healthcare, LLC | 11/04/2021Open, Classified |
| Z-0519-2022 Class II | GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the… | GE Healthcare, LLC | 11/04/2021Open, Classified |
| Z-0518-2022 Class II | GE Vscan Extend, being sold as "Vscan Extend Console"The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the… | GE Healthcare, LLC | 11/04/2021Open, Classified |
| Z-0398-2022 Class II | VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAXThere is potential that the VirtuTRAX device will not tighten onto the instrument to be used. | Civco Medical Instruments Co. Inc. | 10/08/2021Terminated |
| Z-0397-2022 Class II | VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAXThere is potential that the VirtuTRAX device will not tighten onto the instrument to be used. | Civco Medical Instruments Co. Inc. | 10/08/2021Terminated |
| Z-0396-2022 Class II | VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAXThere is potential that the VirtuTRAX device will not tighten onto the instrument to be used. | Civco Medical Instruments Co. Inc. | 10/08/2021Terminated |
| Z-0395-2022 Class II | VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAXThere is potential that the VirtuTRAX device will not tighten onto the instrument to be used. | Civco Medical Instruments Co. Inc. | 10/08/2021Terminated |
| Z-2484-2021 Class II | Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models:…Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while… | Philips Ultrasound Inc | 08/06/2021Completed |
| Z-2483-2021 Class II | EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ…Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while… | Philips Ultrasound Inc | 08/06/2021Completed |
| Z-0518-2020 Class II | Site~Rite 8 Ultrasound Systems-intended for diagnostic ultrasound imaging of the human…The indicator may show available charge when the battery is close to depletion. As a result, the Site~Rite 8… | Becton Dickinson & Company | 11/04/2019Terminated |
| Z-0674-2020 Class II | Philips Volcano FFR software used in the following systems connected to the McKesson…Interoperability issue that affects certain systems that use the recalled software when it is connected to… | Volcano Corporation | 11/07/2018Terminated |
| Z-2983-2018 Class II | GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a…The system side of the power cord may break and expose the electrical conductors leading to the risk of shock. | GE Medical Systems Ultrasound & Primary… | 03/22/2018Terminated |
| Z-1891-2018 Class II | Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the…The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in… | Volcano Corporation | 03/22/2018Terminated |
| Z-2333-2018 Class III | ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1…The incorrect IFU was shipped with the product. | Ecolab Inc | 11/22/2017Terminated |
| Z-2332-2018 Class III | ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged…The incorrect IFU was shipped with the product. | Ecolab Inc | 11/22/2017Terminated |
| Z-1777-2018 Class II | Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400…There is a potential for the gel packets to have leaks in the packet seal. | Parker Laboratories, Inc. | 04/13/2017Terminated |
| Z-1091-2016 Class II | BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451.…The firm is providing customers with an updated Operations and Maintenance Manual for each of the… | Verathon, Inc. | 11/30/2015Terminated |
| Z-2136-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | Volcano Corporation | 06/22/2015Terminated |
| Z-2135-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | Volcano Corporation | 06/22/2015Terminated |
| Z-2134-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | Volcano Corporation | 06/22/2015Terminated |
| Z-2133-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | Volcano Corporation | 06/22/2015Terminated |
| Z-2132-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | Volcano Corporation | 06/22/2015Terminated |
| Z-2131-2015 Class II | Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4…A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain… | Volcano Corporation | 06/22/2015Terminated |
| Z-1063-2015 Class II | ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected…There is a low probability the scanner arm will become completely detached from the scanner column. | Siemens Medical Solutions USA, Inc. | 01/12/2015Terminated |
| Z-0145-2015 Class II | Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size:…Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes and on the… | Parker Laboratories, Inc. | 08/06/2014Terminated |
| Z-0215-2015 Class II | AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case…There is a possibility the sterile packaging may fail before the expiration date specified on the package. | Soma Access Systems LLC | 03/24/2014Terminated |
| Z-0373-2014 Class II | GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system…GE became aware of a potential safety issue due to a system slow down and system lock up associated with the… | GE Healthcare, LLC | 10/11/2013Terminated |
| Z-2045-2015 Class II | ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map -…A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's… | Volcano Corp | 09/23/2013Terminated |
| Z-2044-2015 Class II | Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System…A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's… | Volcano Corp | 09/23/2013Terminated |
| Z-2043-2015 Class II | Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System…A limitation in interoperability between the Philips Xper Flex Cardia Physiomonitoring System and Volcano's… | Volcano Corp | 09/23/2013Terminated |
| Z-0027-2014 Class II | P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased…FUJIFILM SonoSite Inc. remove P21x/5-1 Transducer because the firm discovered the Biopsy Bracket Sensor is… | SonoSite, Inc. | 09/11/2013Terminated |
| Z-2202-2013 Class II | Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for…During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k)… | Sonogage Inc | 08/09/2013Terminated |
| Z-0930-2013 Class II | ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed…On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges. | Siemens Medical Solutions USA, Inc. | 01/18/2013Terminated |
| Z-2345-2012 Class II | Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or…The display on the system has the potential to change. In house testing eventually identified the unique… | Volcano Corporation | 08/24/2012Terminated |
| Z-1581-2015 Class II | ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and…In some cases, the system is unable to capture a clip or image during a routine scan. | Siemens Medical Solutions USA, Inc. | 05/11/2012Terminated |
| Z-1956-2012 Class II | CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY…The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the… | Civco Medical Instruments Inc | 05/07/2012Terminated |
| Z-1955-2012 Class II | CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic…The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the… | Civco Medical Instruments Inc | 05/07/2012Terminated |