FDA Product Code
FDA Product Code IYO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1560
510(k) Clearances — 895 records · page 2 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit | Volcano Corporation | 2017-10-25 | Special | PDF ↗ |
| K171594 | Accuro | Rivanna Medical, LLC | 2017-10-20 | Traditional | PDF ↗ |
| K171309 | BR-FHUS Navigation 1.0 | Taihao Medical, Inc. | 2017-09-29 | Traditional | PDF ↗ |
| K172356 | BladderScan Prime PLUS System | Verathon Incorporated | 2017-09-15 | Traditional | PDF ↗ |
| K172142 | FibroScan 430 Mini+ | Echosens | 2017-09-13 | Traditional | PDF ↗ |
| K171301 | Scanmate Flex | Dgh Technology, Inc. | 2017-07-31 | Traditional | PDF ↗ |
| K171824 | Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2017-07-18 | Traditional | PDF ↗ |
| K171766 | Acuson SC2000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2017-07-12 | Traditional | PDF ↗ |
| K171591 | CUBEScan BioCon-900 (Bladder Volume Measurement System) | Mcube Technology Co., Ltd. | 2017-06-22 | Traditional | PDF ↗ |
| K161354 | MELODY, Remote Control System for Ultrasound Probe | Adecho Tech | 2017-06-12 | Traditional | PDF ↗ |
| K162372 | QT Ultrasound Breast Scanner-1 | Qt Ultrasound, LLC | 2017-06-06 | Traditional | PDF ↗ |
| K170133 | FFR V2.5 | Philips Volcano | 2017-05-26 | Traditional | PDF ↗ |
| K170385 | CORE M2 Vascular System | Volcano Corporation | 2017-04-06 | Special | PDF ↗ |
| K162972 | ExactVu High Resolution Micro-Ultrasound System | Exact Imaging | 2016-12-02 | Traditional | PDF ↗ |
| K161968 | MicrUs | Telemed | 2016-11-03 | Traditional | PDF ↗ |
| K161342 | Sonic Window | Analogic Corporation | 2016-06-15 | Special | PDF ↗ |
| K161300 | Acclarix AX8 Diagnostic Ultrasound System | Edan Instruments, Inc. | 2016-05-31 | Special | PDF ↗ |
| K153620 | Enovare Ultrasound System | Oreon Technologies, Inc. | 2016-05-05 | Traditional | PDF ↗ |
| K160792 | Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound | The Prometheus Group | 2016-04-15 | Traditional | PDF ↗ |
| K153581 | Bladder Scanner | Caresono Technology Co., Ltd. | 2016-04-08 | Traditional | PDF ↗ |
| K160420 | SpeqT | Signostics Limited | 2016-03-21 | Traditional | PDF ↗ |
| K160524 | FibroScan 530 Compact | Echosens | 2016-03-18 | Special | PDF ↗ |
| K153416 | ArcScan Insight 100 | Arcscan, Inc. | 2016-02-02 | Special | PDF ↗ |
| K153369 | SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5iz | Volcano Corporation | 2015-12-22 | Special | PDF ↗ |
| K152554 | Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology | C.R. Bard, Inc. | 2015-12-14 | Traditional | PDF ↗ |
| K152573 | 4Sight | Accutome, Inc. | 2015-11-25 | Traditional | PDF ↗ |
| K153101 | BladderScan Prime System | Verathon Incorporated | 2015-11-19 | Traditional | PDF ↗ |
| K152318 | MD-2300S Ultrasonic A/B Scanner for Ophthalmology | MEDA Co., Ltd. | 2015-11-17 | Traditional | PDF ↗ |
| K152316 | iLab Ultrasound Imaging System | Boston Scientific | 2015-09-18 | Special | PDF ↗ |
| K151339 | SONON Ultrasound Imaging System (Model: SONON 300C) | Healcerion Co., Ltd. | 2015-09-10 | Traditional | PDF ↗ |
| K150239 | FibroScan | Echosens | 2015-09-01 | Traditional | PDF ↗ |
| K151709 | Hi-Light Diagnostic Ultrasound Systems | Qingdao Hisense Medical Equipment Co., Ltd. | 2015-07-17 | Traditional | PDF ↗ |
| K151060 | Ultrasound System SONIMAGE HS1 | Konica Minolta, Inc. | 2015-06-05 | Traditional | PDF ↗ |
| K150949 | FibroScan | Echosens | 2015-06-03 | Traditional | PDF ↗ |
| K150342 | Touch Ultrasound | Carestream Health, Inc. | 2015-05-08 | Traditional | PDF ↗ |
| K150999 | Acclarix Diagnostic Ultrasound System | Edan Instruments, Inc. | 2015-05-06 | Traditional | PDF ↗ |
| K150580 | UltraVision 2 Diagnostic Ultrasound System | Winprobe Corporation | 2015-04-07 | Traditional | PDF ↗ |
| K150529 | Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System | C.R. Bard, Inc. | 2015-03-30 | Special | PDF ↗ |
| K150441 | Volcano iFR Modality, iFR Scout feature | Volcano Corporation | 2015-03-20 | Special | PDF ↗ |
| K143122 | Volcano iFR Harvest Software (Offline) | Volcano Corporation | 2015-02-20 | Special | PDF ↗ |
| K143396 | omni TRAX Active Patient Tracker | Civco Medical Instruments CO Inc Dba Civco Medical Solutions | 2015-01-23 | Traditional | PDF ↗ |
| K143493 | SignosRT Bladder Ultrasound System | Signostics, Ltd. | 2015-01-14 | Traditional | PDF ↗ |
| K142329 | BBS REVOLUTION | Dbmedx, Inc. | 2014-12-15 | Abbreviated | PDF ↗ |
| K142517 | SoftVue | Delphinus Medical Technologies, Inc. | 2014-10-31 | Traditional | PDF ↗ |
| K142443 | Site-Rite 6 Ultrasound System with Pinpoint GT Technology | C.R. Bard, Inc. | 2014-10-30 | Traditional | PDF ↗ |
| K142054 | IMACOR ZURA EVO IMAGING SYSTEM | Imacor, Inc. | 2014-09-29 | Traditional | PDF ↗ |
| K141806 | CLEAR GUIDE ONE | Clear Guide Medical | 2014-09-19 | Traditional | PDF ↗ |
| K142395 | SC2000 and ACUSON X300 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014-09-09 | Traditional | PDF ↗ |
| K140428 | ULTRASOUND SCANNER SYSTEM BK2300 | B-K Medical Aps | 2014-05-30 | Abbreviated | PDF ↗ |
| K140899 | HALO MEDICAL TECHNOLOGIES CATALYST MIDCRYSTL HALO ULTRASOUND SYSTEM | Halo Medical Technologies, LLC | 2014-05-05 | Traditional | PDF ↗ |
| K140199 | VUPAD | Sonomed, Inc. | 2014-04-01 | Traditional | PDF ↗ |
| K133323 | VOLCANO IFR MODALITY | Volcano Corporation | 2014-03-14 | Traditional | PDF ↗ |
| K132736 | ACCURO 3000 ULTRASOUND SCANNER | Rivanna Medical, LLC | 2014-03-11 | Traditional | PDF ↗ |
| K140291 | VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS | Volcano Corporation | 2014-03-07 | Special | PDF ↗ |
| K140126 | SONIC WINDOW | Analogic Corporation | 2014-03-04 | Abbreviated | PDF ↗ |
| K132346 | ULTRASOUND SCANNER PRO FOCUS 2202 | B-K Medical Aps | 2014-01-10 | Traditional | PDF ↗ |
| K133641 | CORE CONTROL PAD, CORE SERIES SW V3.4 INSTALLATION KIT, CORE, CORE MOBILE | Volcano Corporation | 2013-12-20 | Special | PDF ↗ |
| K123209 | SOFTVUE | Delphinus Medical Technologies, Inc. | 2013-12-19 | Traditional | PDF ↗ |
| K133142 | VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION FOR INTEGRATED SYSTEM,VOLCANO S5 PRECISION | Volcano Corporation | 2013-11-15 | Special | PDF ↗ |
| K132654 | ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013-09-26 | Traditional | PDF ↗ |
| K131830 | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Edan Instruments, Inc. | 2013-09-17 | Traditional | PDF ↗ |
| K132228 | UGEO PT60A DIAGNOSTIC ULTRASOUND SYSTEM | Samsung Medison Co., Ltd. | 2013-08-20 | Traditional | PDF ↗ |
| K131690 | M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013-07-24 | Special | PDF ↗ |
| K131227 | PADSCAN HD SERIES BLADDER SCANNER | Carenoso Technology Co., Ltd. | 2013-07-12 | Traditional | PDF ↗ |
| K131489 | TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION | Tractus Corporation | 2013-06-25 | Traditional | PDF ↗ |
| K130944 | ISR'OBOT MONA LISA | Biobot Surgical Pte., Ltd. | 2013-06-07 | Special | PDF ↗ |
| K121243 | ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER | MEDA Co., Ltd. | 2013-05-03 | Traditional | PDF ↗ |
| K123806 | FIBROSCAN | Echosens | 2013-04-05 | Traditional | PDF ↗ |
| K130229 | PALM BLADDER SCANNER | Mianyang Meike Electronic Equipment Co., Ltd. | 2013-03-20 | Abbreviated | PDF ↗ |
| K130243 | ILAB ULTRASOUND IMAGING SYSTEM | Boston Scientific Corp | 2013-03-01 | Special | PDF ↗ |
| K123349 | A-SCAN PLUS CONNECT | Accutome, Inc. | 2013-01-29 | Special | PDF ↗ |
| K123535 | ILAB ULTRASOUND IMAGING SYSTEM | Boston Scientific Corp | 2013-01-15 | Special | PDF ↗ |
| K123898 | VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM | Volcano Corporation | 2013-01-14 | Special | PDF ↗ |
| K123616 | PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM | Sonoscape Company Limited | 2012-12-21 | Special | PDF ↗ |
| K123185 | DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012-11-02 | Traditional | PDF ↗ |
| K122574 | DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL D3 AND D6 | Edan Instruments, Inc. | 2012-10-12 | Traditional | PDF ↗ |
| K121689 | VITASCAN LT SCANMASTER | Vitacon Medical, Inc. | 2012-09-19 | Traditional | PDF ↗ |
| K121479 | AIM | Inneroptic Technology, Inc. | 2012-09-13 | Traditional | PDF ↗ |
| K121422 | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM | Toshiba Medical Systems Coporation, Japan | 2012-08-16 | Special | PDF ↗ |
| K121888 | E-CUBE 15 | Alpinion Medical Systems Co., Ltd. | 2012-07-26 | Traditional | PDF ↗ |
| K111818 | SONIXGPS NEEDLE SENSOR | Ultrasonix Medical Corporation | 2012-06-13 | Traditional | PDF ↗ |
| K121381 | VIEWFLEX XTRA ICE CATHETER | St Jude Medical | 2012-06-07 | Special | PDF ↗ |
| K120882 | SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE | Bard Access Systems, Inc. | 2012-05-30 | Traditional | PDF ↗ |
| K120201 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Ge Vingmed Ultrasound AS | 2012-04-19 | Traditional | PDF ↗ |
| K113304 | BLADDER SCANNER | MEDA Co., Ltd. | 2012-03-23 | Traditional | PDF ↗ |
| K112539 | CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE | Leiker Regulatory & Quality Consulting | 2012-01-30 | Traditional | PDF ↗ |
| K113486 | VOLCANO S5I INTRAVASCULAR ULTRACOUND IMAGING AND PRESSURE SYSTEM | Volcano Corporation | 2012-01-27 | Special | PDF ↗ |
| K113632 | DP-5 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM DP-7 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. | 2012-01-25 | Special | PDF ↗ |
| K113680 | SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT | Soma Access Systems, LLC | 2011-12-29 | Traditional | PDF ↗ |
| K113153 | DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2011-11-28 | Special | PDF ↗ |
| K113156 | SONOSITE EDGE ULTRASOUND SYSTEM | Sonosite,Inc. | 2011-11-15 | Traditional | PDF ↗ |
| K112022 | DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Advanced Instrumentations, Inc. | 2011-09-22 | Traditional | PDF ↗ |
| K111347 | ISROBOT MONA LISA | Biobot Surgical Pte., Ltd. | 2011-08-12 | Traditional | PDF ↗ |
| K111706 | VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM | Volcano Corporation | 2011-07-15 | Special | PDF ↗ |
| K111435 | DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2011-07-08 | Special | PDF ↗ |
| K110688 | MYLABGOLD | Esaote | 2011-06-02 | Traditional | PDF ↗ |
| K102253 | ECHO BLASTER | Telemed | 2011-03-14 | Traditional | PDF ↗ |
| K103148 | AIDA DIAGNOSTIC ULTRASOUND SYSTEM | Panasonic Healthcare Co., Ltd. | 2011-03-11 | Traditional | PDF ↗ |
| K102153 | MOBIUS ULTRASOUND IMAGING SYSTEM | Mobisante, Inc. | 2011-01-20 | Traditional | PDF ↗ |
| K103608 | I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND | Ellex, Inc. | 2010-12-27 | Special | PDF ↗ |
Product code IYO · Class II · Radiology. Data: openFDA.