OWB
323 FDA 510(k) clearances · Product code
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Cios Select (VA21) Image Intensifier (K210307) | Siemens Medical Solutions USA, Inc. | 2021-03-04 |
| ClarifEye R1.0, ClarifEye Needle (K201743) | Philips Medical Systems Nederlands B.V. | 2021-02-23 |
| SmartCT R1.0 (K201583) | Philips Medical Systems Nederland B.V. | 2021-02-09 |
| Cios Spin (K210054) | Siemens Medical Systems USA, Inc. | 2021-02-05 |
| Cios Alpha (K210055) | Siemens Medical Solutions USA, Inc. | 2021-02-05 |
| ControlRad Select Model Z (K202431) | Controlrad, Inc. | 2020-12-23 |
| Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X (K203281) | Medphoton GmbH | 2020-12-22 |
| Cios Flow (K203504) | Siemens Medical Solutions USA, Inc. | 2020-12-22 |
| Alphenix, INFX-8000V/B, /S, V9.1 (K203551) | Canon Medical Systems Corporation | 2020-12-18 |
| Ziehm Vision RFD 3D (K202360) | Ziehm Imaging GmbH | 2020-09-16 |
| Digiscan FDX (K200218) | Allengers Medical Systems Limited | 2020-07-13 |
| ARTIS pheno (VE2) (K201156) | Siemens Medical Solution USA, Inc. | 2020-06-29 |
| ControlRad Trace Model 9 (K200663) | Controlrad, Inc. | 2020-06-24 |
| CFP-3131, CFP-2222 (K201172) | Mx Imaging, Inc. | 2020-05-29 |
| Azurion R2.1 (K200917) | Philips Medical Systems Nederland B.V. | 2020-05-01 |
| O-arm O2 Imaging System (K200074) | Medtronic, Inc. | 2020-04-24 |
| ARTIS Icono (K193326) | Siemens Medical Solutions USA, Inc. | 2020-04-16 |
| AS-10 (K200887) | Canon, Inc. | 2020-04-15 |
| FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System (K200022) | Livermoretech, Inc. | 2020-04-03 |
| TrackX (K200360) | Track X Technology, LLC | 2020-03-05 |
| C015 (K192182) | Micronica Srl | 2020-01-17 |
| Ziehm Vision FD (K193230) | Ziehm Imaging GmbH | 2019-12-20 |
| uMC 560i (K183144) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-12-19 |
| Ziehm 8000 (K190497) | Ziehm Imaging GmbH | 2019-11-20 |
| ARTIS icono (K190768) | Siemens Medical Solutions USA, Inc. | 2019-09-12 |
| MobileRay Pulse SE Digital Imaging System (K191503) | Portavision Medical, LLC | 2019-09-04 |
| ARCO FP (K182086) | A.T.S. Applicazione Tecnologie Speciali S.R.L. | 2019-08-20 |
| nView system 1 (K190064) | Nview Medical, Inc. | 2019-07-08 |
| ControlRad Trace Model 8 (K183109) | Controlrad, Inc. | 2019-05-13 |
| SyncVision System (K190626) | Volcano Corporation | 2019-04-12 |
| Zenition 50 (K183101) | Philips Medical Systems Nederland B.V. | 2018-12-31 |
| Zenition 70 (K183040) | Philips Medical Systems Nederland B.V. | 2018-12-06 |
| Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR (K181403) | GE Healthcare | 2018-11-02 |
| Cios Spin (K181550) | Siemens Medical Solutions USA, Inc. | 2018-10-30 |
| Cios Alpha (K181560) | Siemens Medical Systems USA, Inc. | 2018-10-24 |
| Alphenix, INFX-8000H/B, V8.0 (K182546) | Canon Medical Systems Corporation | 2018-10-17 |
| Alphenix, INFX-8000F/B, V8.0 (K182415) | Canon Medical Systems Corporation | 2018-09-28 |
| XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 (K181415) | Canon Medical Systems Corporation | 2018-09-10 |
| SmartPerfusion (K181966) | Philips Medical Systems Nederlands B.V. | 2018-08-17 |
| Cios Select (K181767) | Siemens Medical Solutions USA, Inc. | 2018-08-17 |
| OSCAR (OSCAR Prime, OSCAR Classic) (K181943) | Genoray Co., Ltd. | 2018-08-17 |
| Artis zee/zeego & Artis Q/Q.zen (K181407) | Siemens Medical Solution USA, Inc. | 2018-08-15 |
| Azurion R2.0 (K181830) | Philips Medical Systems Nederland B.V. | 2018-08-02 |
| Alphenix, INFX-8000C/B, V8.0 (K181804) | Canon Medical Systems Corporation | 2018-08-02 |
| Alphenix, INFX-8000V/B, V8.0 (K181670) | Canon Medical Systems Corporation | 2018-07-25 |
| Ultimax-i, DREX-UI80 (V1.60) (K181834) | Canon Medical Systems Corporation | 2018-07-19 |
| Intelli-C (K173631) | Nrt X-Ray A/S | 2018-07-11 |
| Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax (K173639) | Siemens Medi Cal Solutions, Inc. | 2018-04-02 |
| ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR (K180473) | Ecotron Co., Ltd. | 2018-03-23 |
| TrackX (K173736) | Track X Technology, LLC | 2018-02-28 |
| OSCAR 15 (K172180) | Genoray Co., Ltd. | 2018-02-09 |
| CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System (K171755) | Omega Medical Imaging, LLC | 2018-02-09 |
| ProxiDiagnost N90 (K173433) | Philips Medical Systems Dmc GmbH | 2018-02-05 |
| Medtronic O-arm O2 Imaging System (K173664) | Medtronic, Inc. | 2017-12-29 |
| Infinix-i, INFX-8000V, V7.0 (K172863) | Toshibamedical Systems Corporation | 2017-12-14 |
| Azurion series R1.2 (K172822) | Philips Medical Systems Nederland B.V. | 2017-11-22 |
| LessRay System (K173314) | Nu Vasive, Incorporated | 2017-11-16 |
| OEC One (K172700) | Ge Hualun Medical Systems Co. , Ltd. | 2017-11-09 |
| XIDF-AWS801, Angio Workstation, V7.0 (K172646) | Toshibamedical Systems Corporation | 2017-10-30 |
| Dynamic Coronary Roadmap 2.0 (K172307) | Philips Medical Systems Nederland B.V. | 2017-10-24 |
| SyncVision System (K172574) | Volcano Corporation | 2017-10-05 |
| EndoNaut (K171829) | Therenva Sas | 2017-09-21 |
| NuVasive LessRay with Enhanced Tracking (K170800) | Nu Vasive, Incorporated | 2017-08-18 |
| OEC Elite (K171565) | Ge Oec Medical Systems, Inc. | 2017-08-10 |
| Ultimax-i, DREX-UI80 V1.60 (K170832) | Toshibamedical Systems Corporation | 2017-07-21 |
| Infinix INFX-8000V, V6.40 (K170909) | Toshiba Medical Systems Coroporation | 2017-06-16 |
| StentBoost Live (K170144) | Philips Medical Stystems Nederland BV | 2017-06-07 |
| Dynamic Coronary Roadmap (K170130) | Philips Medical Systems Nederland B.V. | 2017-06-02 |
| SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System (K163140) | Gemss Medical Systems Co., Ltd. | 2017-05-26 |
| AS-10, CXDI-401RF (K171194) | Canon, Inc. | 2017-05-24 |
| OEC Elite (K170752) | Oec Medical Systems, Inc. | 2017-05-19 |
| ARTIS pheno (K163286) | Siemens Medical Solution USA, Inc. | 2017-03-09 |
| Allura Xper R9 (K163715) | Philips Medical Systems Nederland B.V. | 2017-01-26 |
| Allura Xper FD series and Allura Xper OR Table series (K162859) | Philips Medical Systems Nederland B.V. | 2016-12-02 |
| Allura Xper R9 (K162148) | Philips Medical Systems Nethrlands BV | 2016-11-23 |
| Infinix, INFX-8000V, V6.35 (K162614) | Toshibamedical Systems Corporation | 2016-10-17 |
| ANYVIEW-500R Fluoroscopic Mobile X-Ray System (K160279) | Ecotron Co., Ltd. | 2016-10-14 |
| Ziehm Solo FD (K161976) | Ziehm Imaging GmbH | 2016-10-06 |
| SyncVision System (K161756) | Volcano Corporation | 2016-09-05 |
| AneurysmFlow (K160455) | Philips Medical Systems Nederland B.V. | 2016-08-25 |
| CT TrueView (K160147) | Philips Medical Systems Nederland B.V. | 2016-08-10 |
| 2D Quantitative Analysis (K161839) | Philips Medical Systems Nederland B.V. | 2016-07-29 |
| Allura Xper FD series and Allura Xper OR Table series (K161563) | Philips Medical Systems Nederland B.V. | 2016-07-29 |
| Cydar EV (K160088) | Cydar , Ltd. | 2016-07-07 |
| Cios Fusion (K153244) | Siemens Medical Solutions USA, Inc. | 2016-03-07 |
| Cios Select (K153232) | Siemens Medical Solutions USA, Inc. | 2016-02-10 |
| INFX-8000C, V6.20 (K152697) | Toshibamedical Systems Corporation | 2016-01-15 |
| Cios Connect (K153147) | Siemens Medical Solutions USA, Inc. | 2016-01-12 |
| INFX-8000V, V6.20 (K152696) | Toshibamedical Systems Corporation | 2016-01-12 |
| XIDF-AWS801, Angio Workstation, V6.20 (K152785) | Toshibamedical Systems Corporation | 2015-11-25 |
| Multitom Rax (K152928) | Siemens Medical Solutions USA, Inc. | 2015-11-13 |
| VesselNavigator Rel. 1.0 (K151598) | Philips Medical Systems Nederland B.V. | 2015-08-17 |
| O-Arm O2 Imaging System (K151000) | Medtronic, Inc. | 2015-08-06 |
| SyncVision System (K151904) | Volcano Corporation | 2015-07-31 |
| XIDF-AWS801, Angio Workstation, V6.10 (K150967) | Toshibamedical Systems Corporation | 2015-06-18 |
| Ziehm Vision RFD 3D (K142740) | Ziehm Imaging GmbH | 2015-04-06 |
| XIDF-AWS801, Angio Workstation, v5.31 (K142736) | Toshibamedical Systems Corporation | 2015-03-11 |
| EmboGuide (K142273) | Philips Medical Systems Nederland B.V. | 2015-01-30 |
| Ultimax-i (K143281) | Toshibamedical Systems Corporation | 2015-01-29 |
| INFX-8000V with Wireless Footswitch (K143225) | Toshibamedical Systems Corporation | 2015-01-09 |
Track OWB automatically
Every clearance here is in the API, with alerts when new ones post.