System, X-Ray, Fluoroscopic, Image-Intensified
FDA product code JAA · Class II (moderate risk) · 21 CFR 892.1650 · Radiology
300510(k) clearances
0PMA approvals
194recalls
Manufacturers
- Toshiba America Medical Systems, In.C 13
- Shimadzu Medical Systems 10
- Siemens Medical Solutions USA, Inc. 10
- General Electric Co. 10
- Fischer Imaging Corp. 10
- Eigen 9
- Shimadzu Corp. 9
- Omega Medical Imaging, Inc. 8
- Adac Laboratories 7
- Philips Medical Systems (Cleveland) Inc 6
- Oec-Diasonics, Inc. 5
- Philips Medical Systems Dmc GmbH 5
- Dornier Medtech America, Inc. 5
- Perkins Mfg. Co. 4
- Electromek Diagnostic Systems, Inc. 4
- Philips Medical Systems 4
- Continental X-Ray Corp. 4
- Philips Medical Systems North America, Inc. 4
- Imaging Engineering, LLC 4
- Cmt Medical Technologies, Ltd. 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253103 | Nexus DRF Digital X-ray Imaging SystemJAA · Traditional | Varex Imaging Corporation | 05/29/2026SE |
| K251650 | Insight Enhanced DRF (EN-1002-01)JAA · Traditional | Imaging Engineering, LLC | 09/16/2025SE |
| K242488 | Soteria E-ViewJAA · Traditional | Omega Medical Imaging, LLC | 01/06/2025SE |
| K242948 | Adora DRFi (04550010)JAA · Traditional | Nrt X-Ray A/S | 12/23/2024SE |
| K233380 | TRIDENT Mobile Fluoroscopy SystemJAA · Traditional | Dornier Medtech America | 06/26/2024SE |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA · Special | Philips Medical Systems Dmc GmbH | 01/11/2024SE |
| K232910 | CombiDiagnost R90JAA · Special | Philips Medical Systems Dmc GmbH | 10/19/2023SE |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5JAA · Special | Canon Medical Systems Corporation | 09/12/2023SE |
| K220871 | NautilusJAA · Special | Dornier Medtech America, Inc. | 04/18/2022SE |
| K212890 | Nyquist.IQJAA · Traditional | Omega Medical Imaging, LLC | 12/13/2021SE |
| K212837 | ProxiDiagnost N90JAA · Special | Philips Medical Systems Dmc GmbH | 09/21/2021SE |
| K212145 | DR 800 with DSA, DR 800JAA · Traditional | Agfa N.V. | 08/31/2021SE |
| K210469 | Insight Agile DRFJAA · Traditional | Imaging Engineering, LLC | 07/27/2021SE |
| K203428 | Ziehm Vision RFDJAA · Special | Ziehm Imaging GmbH | 03/17/2021SE |
| K203010 | Platinum dRF Imaging SystemJAA · Special | Apelem-Dms Group | 01/22/2021SE |
| K200965 | XR-MX/1000JAA · Traditional | Karl Storz Endoscopy America, Inc. | 12/29/2020SE |
| K203087 | CombiDiagnost R90JAA · Traditional | Philips Medical Systems Dmc GmbH | 12/03/2020SE |
| K202235 | ArtPIX DRFJAA · Special | Cmt Medical Technologies, Ltd. | 09/03/2020SE |
| K200396 | Insight Enhanced DRF Digital Imaging SystemJAA · Special | Imaging Engineering, LLC | 03/06/2020SE |
| K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield…JAA · Traditional | Omega Medical Imaging, LLC | 10/04/2019SE |
| K191504 | PowerDRJAA · Traditional | Radiology Information Systems, Inc. | 08/16/2019SE |
| K191877 | FLUOROspeedJAA · Special | Shimadzu Corporation | 08/05/2019SE |
| K191310 | Insight Essentials DRF Digital Imaging SystemJAA · Traditional | Imaging Engineering, LLC | 06/10/2019SE |
| K182834 | CS-series-FP with Optional ROI Accessory CA-100SJAA · Traditional | Omega Medical Imaging, LLC | 03/29/2019SE |
| K190373 | SonialVision G4JAA · Special | Shimadzu Corporation | 03/15/2019SE |
| K173395 | MECALL CLISIS SYSTEMS, Discovery RF180JAA · Special | General Medical Merate S.P.A | 05/21/2018SE |
| K180651 | Uroview FD IIJAA · Traditional | Pausch Medical GmbH | 04/12/2018SE |
| K180589 | DR 800 with MUSICA DynamicJAA · Traditional | Agfa Healthcare N.V. | 04/05/2018SE |
| K163210 | Philips CombiDiagnost R90JAA · Traditional | Philips Medical Systems Dmc GmbH | 01/31/2017SE |
| K161019 | Uroview FDJAA · Traditional | Pausch Medical GmbH | 08/17/2016SE |
| K160301 | Platinum dRF Imaging SystemJAA · Special | Apelem-Dms Group | 03/04/2016SE |
| K150306 | D2RS_AT Digital Dynamic Remote SystemJAA · Traditional | Stephanix Radiological Solutions | 10/10/2015SE |
| K151485 | GenesisJAA · Special | Dornier Medtech America, Inc. | 06/30/2015SE |
| K142341 | X-Ray TV System Sonialvision G4JAA · Abbreviated | Shimadzu Corp. | 03/06/2015SE |
| K133434 | Genesis IIJAA · Traditional | Dornier Medtech America, Inc. | 11/26/2014SE |
| K140380 | Opera SwingJAA · Traditional | General Medical Merate S.P.A | 09/26/2014SE |
| K141541 | XIDF-AWS801, Angio Workstation, V5.31JAA · Traditional | Toshibamedical Systems Corporation | 09/08/2014SE |
| K132289 | Gemss Medical Systems Surgical Mobile Fluoroscopic X-Ray SystemJAA · Traditional | Gemss Medical Systems Co., Ltd. | 06/16/2014SE |
| K133553 | KalareJAA · Traditional | Toshiba America Medical Systems, In.C | 06/13/2014SE |
| K131075 | X-Ray TV System Sonial Vision G4JAA · Abbreviated | Shimadzu Corp. | 03/28/2014SE |
| K131766 | Platinum DRF Imaging SystemJAA · Traditional | Apelem-Dms Group | 12/12/2013SE |
| K132904 | Ziehm Vision RFDJAA · Special | Ziehm Imaging GmbH | 12/05/2013SE |
| K132106 | Infinix Angio Workstation W/Dts SoftwareJAA · Traditional | Toshiba America Medical Systems, In.C | 11/12/2013SE |
| K130318 | Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)JAA · Special | Varian Medical Systems, X-Ray Products-Infimed | 04/22/2013SE |
| K123097 | Dose Tracking System Model XIDF-DTS801JAA · Traditional | Toshiba America Medical Systems, In.C | 02/13/2013SE |
| K122768 | GenesisJAA · Traditional | Dornier Medtech America, Inc. | 01/18/2013SE |
| K121293 | Cs-Series-Fp with 3030+OPTIONJAA · Traditional | Omega Medical Imaging, LLC | 07/26/2012SE |
| K112054 | Infinix Cf-I/Sp and Infinix Vf-I/Sp Model INFX-8000VJAA · Special | Toshiba Medical Systems Corporation, Japan | 08/05/2011SE |
| K111292 | Luminos AgileJAA · Special | Siemens Medical Solutions USA, Inc. | 06/03/2011SE |
| K110785 | Kalare Diagnostic X-Ray Table SystemJAA · Traditional | Toshiba Medical Systems Coporation, Japan | 05/27/2011SE |
| K103038 | Duet DRFJAA · Abbreviated | Cmt Medical Technologies, Ltd. | 03/29/2011SE |
| K101491 | Uroskop OmniaJAA · Special | Siemens Medical Solutions USA, Inc. | 06/30/2010SE |
| K082830 | INFX-8000H, Infinix-IJAA · Traditional | Toshiba America Medical Systems, In.C | 10/10/2008SE |
| K081621 | INFX-8000C (Infinix Cc-I and Vc-I)JAA · Traditional | Toshiba America Medical Systems, In.C | 06/23/2008SE |
| K081491 | Smith & Nephew CDS SystemJAA · Special | Smith & Nephew, Inc. | 06/19/2008SE |
| K081582 | INFX-8000V, Infinix-Cfi and Infinix VfiJAA · Traditional | Toshiba America Medical Systems, In.C | 06/17/2008SE |
| K081091 | Precision 500D R&F X-Ray SystemJAA · Traditional | GE Healthcare | 06/11/2008SE |
| K080859 | DRF 4343JAA · Traditional | Villa Sistemi Medicali S.P.A. | 06/04/2008SE |
| K070390 | Fluoropro RF Digital Imaging SystemJAA · Traditional | Virtual Imaging, Inc. | 04/05/2007SE |
| K061028 | Precision Thunis 800+JAA · Abbreviated | Ge Medical Systems, LLC | 06/07/2006SE |
| K052610 | Image Star IIJAA · Traditional | Lakeshore Technologies, Inc. | 11/30/2005SE |
| K051602 | Axiom Sireskop SDJAA · Traditional | Siemens Medical Systems, Inc. | 07/07/2005SE |
| K051136 | Smith & Nephew CDS SystemJAA · Traditional | Smith & Nephew, Inc. | 07/01/2005SE |
| K051025 | Fluoroscan Insight Mini C-Arm Fluoroscopic Imaging SystemJAA · Special | Hologic, Inc. | 05/13/2005SE |
| K050866 | Centrion 500 C-Arm SystemJAA · Traditional | Osteosys Co.,Ltd | 04/27/2005SE |
| K050692 | FlxisJAA · Traditional | Philips Medical Systems North America Co. | 04/08/2005SE |
| K042698 | Unfors Patient Skin Dosimeter (PSD)JAA · Traditional | Unfors, Inc. | 10/22/2004SE |
| K040870 | Shimadzu Image Amplifier, Model IA-16L/HSJAA · Traditional | Shimadzu Corp. | 05/17/2004SE |
| K024012 | Oec 9800 E/Cv+ Digital Mobile Imaging SystemJAA · Traditional | Ge Oec Medical Systems | 03/20/2003SE |
| K022911 | Model AMI1200 C-ArmJAA · Traditional | Integrity Practice Management, Inc. | 12/02/2002SE |
| K022899 | Philips Integris Allura Flat Detector Release 1.0JAA · Traditional | Philips Medical Systems North America Co. | 11/22/2002SE |
| K022565 | Telstar Biplane Digital Imaging System [Tis] Model 030-000915JAA · Special | Stereotaxis, Inc. | 10/08/2002SE |
| K021021 | Modular Angiography System Axiom ArtisJAA · Traditional | Siemens Medical Solutions USA, Inc. | 06/06/2002SE |
| K020055 | Philips Integris Allura 9 with FD OptionJAA · Traditional | Philips Medical Systems | 03/15/2002SE |
| K012424 | Shimadzu Image Amplifier Model # IA-16LMJAA · Traditional | Shimadzu Corp. | 10/18/2001SE |
| K010772 | ISI-2500 CCD C-Arm, ISI-2500 Plus CCD C-ArmJAA · Traditional | Imaging Services, Inc. | 08/23/2001SE |
| K011624 | Expedio 500D R&F X-Ray SystemJAA · Traditional | GE Medical Systems | 06/08/2001SE |
| K010392 | Athena Remote Controlled RF SystemJAA · Traditional | Cares Built, Inc. | 03/12/2001SE |
| K010187 | Kimax, Model 1024JAA · Abbreviated | Medical Metrics, Inc. | 02/14/2001SE |
| K004037 | X-Ray System Xr-MxJAA · Traditional | Karl Storz Endoscopy | 02/02/2001SE |
| K000987 | VFSS Imager, Model SIS-300JAA · Traditional | Lifecare Imaging Intl., Ltd. | 06/01/2000SE |
| K993896 | MCA-601, C-Arm MobileJAA · Traditional | Medison Radiology Systems, Inc. | 03/27/2000SE |
| K992603 | XRT 600 R/F, WRF 0600JAA · Traditional | Wuestec Medical, Inc. | 10/25/1999SE |
| K993038 | Toshiba RTP9211J-G11, J-Advanced Image Intensifier (I.I.)JAA · Traditional | Toshiba America Medical Systems, In.C | 10/07/1999SE |
| K990055 | B-400 Ceiling Mounted Possitioner, Model B-400JAA · Traditional | Omega Medical Imaging, Inc. | 02/02/1999SE |
| K982319 | CaregraphJAA · Traditional | Siemens Medical Solutions USA, Inc. | 09/22/1998SE |
| K982345 | Vasco Scanning Beam Digital X-Ray SystemJAA · Traditional | Cardiac Mariners, Inc. | 09/01/1998SE |
| K981414 | LC PositionerJAA · Traditional | Fischer Imaging Corp. | 07/16/1998SE |
| K982028 | Fluorospot CompactJAA · Traditional | Siemens Medical Solutions USA, Inc. | 07/14/1998SE |
| K981227 | Symphony 360 Remote Control TableJAA · Traditional | Acoma Medical Imaging, Inc. | 06/30/1998SE |
| K974058 | FS IV Mini C-Arm SystemJAA · Traditional | Hologic, Inc. | 01/12/1998SE |
| K973744 | Unicath SP Bi-Plane (Model M269 & M289)JAA · Traditional | Xre Corp. | 12/29/1997SE |
| K973067 | DRTS Remote Control DrapeJAA · Traditional | Minrad, Inc. | 10/16/1997SE |
| K973073 | DRTS Image Intensifier DrapeJAA · Traditional | Minrad, Inc. | 10/08/1997SE |
| K972442 | Ceiling Mounted Lateral Positioner, Model No. 6896.002JAA · Traditional | Continental X-Ray Corp. | 09/11/1997SE |
| K970947 | B-350 Ceiling Mounted C-PositionerJAA · Traditional | Omega Medical Imaging, Inc. | 05/14/1997SE |
| K970608 | Evt Marker BoardJAA · Traditional | Guidant Cardiac and Vascular Surgery | 04/21/1997SE |
| K961782 | Bio-BinkiJAA · Traditional | Biomni Medical Systems, Inc. | 03/28/1997SE |
| K964990 | Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System (SX-VA30)JAA · Traditional | Hitachi Medical Systems America, Inc. | 02/26/1997SE |
| K964322 | Vipor UnitJAA · Traditional | Tilane Corp. | 02/26/1997SE |
| K963888 | C-Arm Table IVS-100JAA · Traditional | Shimadzu Medical Systems | 12/18/1996SE |
| K963617 | Shimadzu X-Ray Diagnostic Table YSF-120JAA · Traditional | Shimadzu Medical Systems | 11/08/1996SE |
| K961140 | Fluoroplus Cardiac TVJAA · Traditional | Cmt Medical Technologies, Ltd. | 09/20/1996SE |
| K953974 | Camvision 1000JAA · Traditional | Medivision Medical Imaging, Ltd. | 09/09/1996SE |
| K961207 | Ep-X BiplaneJAA · Traditional | Fischer Imaging Corp. | 08/20/1996SE |
| K962606 | Topographic Imaging MarkerJAA · Traditional | I.Z.I. Medical Products Corp. | 08/07/1996SE |
| K962140 | ICT-2000, Integrated C-Arm/Table Multipurpose Radiographic/Fluoroscopic Positioning…JAA · Traditional | Continental X-Ray Corp. | 07/25/1996SE |
| K961690 | Cardioarc Series: Positioner C-Arm Models No. 6896.001 and 6896.105JAA · Traditional | Continental X-Ray Corp. | 06/27/1996SE |
| K961193 | Full Frame Zoom SystemJAA · Traditional | Xre Corp. | 06/17/1996SE |
| K955687 | RNS Sterile, Disposable Radiographic Contrast TrayJAA · Traditional | Contour Fabricators of Florida, Inc. | 06/03/1996SE |
| K953113 | SBDX Mobile Fluoroscopy SystemJAA · Traditional | Cardiac Mariners, Inc. | 03/29/1996SE |
| K951261 | DFI-1000 and DVS-475 Imaging DevicesJAA · Traditional | Nical | 03/15/1996SE |
| K960266 | Siregraph CFJAA · Traditional | Siemens Medical Solutions USA, Inc. | 03/11/1996SE |
| K954945 | Hanel Mavig Monitor Suspension SystemJAA · Traditional | F. Walter Hanel GmbH | 01/29/1996SE |
| K954590 | MAX-1000A/R1JAA · Traditional | Toshiba America Medical Systems, In.C | 11/20/1995SE |
| K953950 | Fluoro CatheterJAA · Traditional | Cmt Medical Technologies, Ltd. | 09/18/1995SE |
| K952493 | Fluorecord Model 762JAA · Traditional | Syracuse Scientific, Inc. | 06/22/1995SE |
| K952456 | Image Intensified Fluoroscopic X-Ray SystemJAA · Traditional | Fisher Imaging Corp. | 06/16/1995SE |
| K950781 | Compact 7600JAA · Traditional | Ge Dec Medical Systems | 06/05/1995SE |
| K946081 | Fluorex DTA-400AJAA · Traditional | Toshiba America Medical Systems, In.C | 05/24/1995SE |
| K951358 | Sireskop SXJAA · Traditional | Siemens Medical Solutions USA, Inc. | 05/15/1995SE |
| K936236 | Shimadzu Image Amplifier IA-12LM SeriesJAA · Traditional | Shimadzu Medical Systems | 05/11/1995SE |
| K950683 | Arthrogram TrayJAA · Traditional | Surgical Technologies, Inc. | 05/06/1995SE |
| K943156 | System, Image ProcessingJAA · Traditional | Image Technology, Inc. | 05/04/1995SE |
| K950971 | Mobil C-Arm, Regurbished, Various ModelsJAA · Traditional | Pro-Tronics, Inc. | 04/11/1995SE |
| K950631 | ID400 Series ArmboardsJAA · Traditional | Image Diagnostics, Inc. | 03/24/1995SE |
| K945460 | Philips CD Medical Recorder, View Station, Dup[[Lication StationJAA · Traditional | Philips Medical Systems North America, Inc. | 03/14/1995SE |
| K941917 | Fluoroplua Cardiac And/Or InstaviewJAA · Traditional | Fidelity Medical, Inc. | 02/24/1995SE |
| K942019 | Model FP-100JAA · Traditional | International Medical Designs, Inc. | 02/01/1995SE |
| K943272 | Visualizer 2000JAA · Traditional | Vf-Works, Inc. | 12/27/1994SE |
| K944973 | NRF SystemJAA · Traditional | Philips Medical Systems (Cleveland), Inc. | 12/14/1994SE |
| K943532 | Panoramic Corporation HDLXJAA · Traditional | Panoramic Corp. | 12/07/1994SE |
| K943447 | V-Max OptionsJAA · Traditional | Philips Medical Systems (Cleveland), Inc. | 11/28/1994SE |
| K943805 | Prestige Remote R & F System Models H, VH & VHDJAA · Traditional | General Electric Co. | 09/23/1994SE |
| K940295 | Uroview Model 2600JAA · Traditional | Ge Dec Medical Systems | 08/22/1994SE |
| K942841 | Oec 901JAA · Traditional | Baldwin | 08/09/1994SE |
| K942674 | Angiorest Table Pad SystemJAA · Traditional | Scribner Browne Medical Design, Inc. | 07/29/1994SE |
| K942264 | DDR with Dpa and 30/60 Options (Digital Viewstation)JAA · Traditional | Eigen Video | 07/20/1994SE |
| K941611 | TDA-4000/A4JAA · Traditional | Toshiba America Medical Systems, In.C | 05/13/1994SE |
| K926560 | Epic (Electrophysiology Imaging ComputerJAA · Traditional | Fischer Imaging Corp. | 05/09/1994SE |
| K933472 | Shimadzu Digital Substraction Syst DAR-2400 SeriesJAA · Traditional | Shimadzu Corp. | 02/07/1994SE |
| K936136 | Uroview Systems Tomography Option SoftwareJAA · Traditional | Ge Dec Medical Systems | 01/25/1994SE |
| K933473 | Catheterization C-Arm Support MH-51BM/MH-51CMJAA · Traditional | Shimadzu Corp. | 11/24/1993SE |
| K933791 | Philips Angiopro Release 2.1JAA · Traditional | Philips Medical Systems North America, Inc. | 11/22/1993SE |
| K934626 | Goodall Laser Targeting DeviceJAA · Traditional | Protectair, Inc. | 11/19/1993SE |
| K933100 | ARC-600JAA · Traditional | B C Medical , Ltd. | 11/08/1993SE |
| K934481 | Ep-XJAA · Traditional | Fischer Imaging Corp. | 11/03/1993SE |
| K933299 | QL Multipulse 2048JAA · Traditional | Infimed, Inc. | 11/03/1993SE |
| K932445 | Sireskop CXJAA · Traditional | Siemens Medical Solutions USA, Inc. | 09/07/1993SE |
| K931941 | Sunscope 100JAA · Traditional | Sunning Corp. | 07/20/1993SE |
| K931268 | Ureteral Compression DeviceJAA · Traditional | Bt Medical Co., Inc. | 07/19/1993SE |
| K930885 | Pneumatic Compression DeviceJAA · Traditional | Bt Medical Co., Inc. | 07/13/1993SE |
| K926064 | Fluoroscopic Brightness Stabalizer/Fbs Model 9205AJAA · Traditional | Scientific Technology , Ltd. | 04/27/1993SE |
| K926434 | SIS-300(N)-DIA ScanJAA · Traditional | Micro-Focus Imaging., Inc. | 03/18/1993SE |
| K926122 | FluorexJAA · Traditional | Toshiba America Medical Systems, In.C | 02/12/1993SE |
| K924879 | Ep 3000JAA · Traditional | Oec-Diasonics, Inc. | 01/04/1993SE |
| K925251 | Lixi Imaging Scope. ModificationJAA · Traditional | Lixi, Inc. | 12/28/1992SE |
| K923107 | Body Band Restraint Strap SetJAA · Traditional | Cook, Inc. | 11/27/1992SE |
| K922977 | ExposetJAA · Traditional | S & S Inficon, Inc. | 11/27/1992SE |
| K924164 | Digital Disk Recorder W/Dualpath ARCHIVE/30-60 OptJAA · Traditional | Eigen | 11/23/1992SE |
| K923585 | Digital Fluoro StoreJAA · Traditional | Eigen | 10/21/1992SE |
| K922274 | Medrad Pathfinder-E Roadmapping SystemJAA · Traditional | Medrad, Inc. | 10/09/1992SE |
| K923454 | Shimadzu Image Amplifier IA-9LS SeriesJAA · Traditional | Shimadzu Medical Systems | 10/05/1992SE |
| K923453 | Shimadzu Image Amplifier IA-9LM SeriesJAA · Traditional | Shimadzu Medical Systems | 10/05/1992SE |
| K923137 | CSL X-Ray ImagescopeJAA · Traditional | Csi Opto-Electronics Corp. | 09/23/1992SE |
| K922240 | Electronic Photospot 20JAA · Traditional | Toshiba America Medical Systems, In.C | 08/07/1992SE |
| K920746 | VFC UnitJAA · Traditional | Tilane Corp. | 06/30/1992SE |
| K922012 | Shimadzu Image Amplifier IA-12VSA SeriesJAA · Traditional | Shimadzu Medical Systems | 06/16/1992SE |
| K922013 | Shimadzu Image Amplifier IA-12VMA SeriesJAA · Traditional | Shimadzu Medical Systems | 06/10/1992SE |
| K922011 | Shimadzu Image Amplifier IA-12VDA SeriesJAA · Traditional | Shimadzu Medical Systems | 06/10/1992SE |
| K920720 | Digital Radiography System IDR-1000JAA · Traditional | Shimadzu Medical Systems | 04/20/1992SE |
| K920721 | Digital Radiography System IDR-2000JAA · Traditional | Shimadzu Medical Systems | 04/15/1992SE |
| K920550 | Display Processor - Model IDP5100JAA · Traditional | Perkins Mfg. Co. | 04/13/1992SE |
| K915405 | P1310 Automatic Brightness Stabilizer (Abs)JAA · Traditional | Precise Optics Photo Medic Equipment, Inc. | 02/04/1992SE |
| K914414 | Video FluoroscopeJAA · Traditional | Raymax Medical Corp. | 01/24/1992SE |
| K913886 | Sony DVR-10 Digital Videocassette RecorderJAA · Traditional | Sony Medical Electronics Co. | 01/24/1992SE |
| K915592 | Pegasus Lateral Cardiac PositionerJAA · Traditional | Fischer Imaging Corp. | 01/13/1992SE |
| K914446 | Uroview 2000, ModificationJAA · Traditional | Oec-Diasonics, Inc. | 01/10/1992SE |
| K905694 | FVP-1000 Family and FVP-1000D FamilyJAA · Traditional | Fischer Imaging Corp. | 11/27/1991SE |
| K914525 | Flurospot H Version 2JAA · Traditional | Siemens Medical Solutions USA, Inc. | 11/19/1991SE |
| K913012 | Digital Fluoro Store(Dfs) W/Numerical SuffixesJAA · Traditional | Eigen | 09/23/1991SE |
| K912896 | Digistore 2100JAA · Traditional | Enhanced Imaging Technologies, Inc. | 08/26/1991SE |
| K912341 | Multicam I 8X10JAA · Traditional | Camtronics, Ltd. | 08/26/1991SE |
| K912470 | Philips Diagnost 96JAA · Traditional | Philips Medical Systems, Inc. | 08/07/1991SE |
| K912380 | Laser Beam Localizer for Siremobil 4JAA · Traditional | Siemens Medical Solutions USA, Inc. | 07/19/1991SE |
| K911454 | FC2000JAA · Traditional | S & S Inficon, Inc. | 07/15/1991SE |
| K910384 | Video Annotator Model PK2310JAA · Traditional | Perkins Mfg. Co. | 04/16/1991SE |
| K905278 | Sts(Tm) Fluoroscopic Imaging ModuleJAA · Traditional | Medstone Intl., Inc. | 02/04/1991SE |
| K905111 | Digital Disk Recorder(Ddr) W/Numerical SuffixesJAA · Traditional | Eigen | 01/25/1991SE |
| K904986 | Programmable Video Controller Model PK2060JAA · Traditional | Perkins Mfg. Co. | 12/04/1990SE |
| K904012 | Philips Integris I 2000 SystemJAA · Traditional | Philips Medical Systems, Inc. | 11/29/1990SE |
| K902982 | G.E. Polarix II C-ArmJAA · Traditional | Electromek Diagnostic Systems, Inc. | 11/13/1990SE |
| K903821 | PSC-1 W/Other NumericalJAA · Traditional | Eigen | 11/07/1990SE |
| K902981 | G.E. Fluorocon 300 Imaging SystemJAA · Traditional | Electromek Diagnostic Systems, Inc. | 11/07/1990SE |
| K902983 | Siemen's Siremobile II C-ArmJAA · Traditional | Electromek Diagnostic Systems, Inc. | 11/06/1990SE |
| K902980 | G.E. XT Ceiling Tube SuspensionJAA · Traditional | Electromek Diagnostic Systems, Inc. | 10/23/1990SE |
| K902583 | Joint Moton Imager(Tm)JAA · Traditional | Concord Imaging, Ltd. | 09/27/1990SE |
| K902005 | Model B-200 C-Arm & Model C-300 Cardiac TableJAA · Traditional | Omega Medical Imaging, Inc. | 09/20/1990SE |
| K901671 | Hafcon (Flouro Footswitch)JAA · Traditional | B & H Research Instruments | 08/08/1990SE |
| K902927 | Digital PhotospotJAA · Traditional | Eigen | 08/03/1990SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0597-2026 Class II | Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL…Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the… | Philips North America | 10/27/2025Open, Classified |
| Z-0463-2026 Class II | Precision CRF; Model Number: 706400;Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through… | Philips Medical Systems DMC GmbH | 10/01/2025Open, Classified |
| Z-0462-2026 Class II | CombiDiagnost R90; Model Number: 709031;Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through… | Philips Medical Systems DMC GmbH | 10/01/2025Open, Classified |
| Z-0461-2026 Class II | ProxiDiagnost N90; Model Number: 706110;Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through… | Philips Medical Systems DMC GmbH | 10/01/2025Open, Classified |
| Z-1982-2025 Class II | UROSKOP Omnia Max. Model Number: 10762473A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the… | Siemens Medical Solutions USA, Inc | 06/04/2025Open, Classified |
| Z-1981-2025 Class II | UROSKOP Omnia. Model Number: 10094910A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the… | Siemens Medical Solutions USA, Inc | 06/04/2025Open, Classified |
| Z-0317-2025 Class II | The FLUOROspeed is intended to be used as a universal diagnostic imaging system for…X-ray R/F system software with certain versions of the control board may occasionally fail to display images… | Shimadzu Corporation Medical Systems Division | 09/06/2024Open, Classified |
| Z-0316-2025 Class II | SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for…X-ray R/F system software with certain versions of the control board may occasionally fail to display images… | Shimadzu Corporation Medical Systems Division | 09/06/2024Open, Classified |
| Z-2738-2024 Class II | DR 800. Digital Radiography X-ray System.Potential for the front lever chain of the DR 800 table to fail. | Agfa N.V. | 07/29/2024Open, Classified |
| Z-1073-2024 Class II | ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F)…Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography… | Philips North America | 12/15/2023Open, Classified |
| Z-1072-2024 Class II | ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system…Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography… | Philips North America | 12/15/2023Open, Classified |
| Z-0280-2024 Class II | ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) systemPotential for units suspended on the ceiling to fail and fall. | Philips North America Llc | 09/21/2023Open, Classified |
| Z-0279-2024 Class II | EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export…Potential for units suspended on the ceiling to fail and fall. | Philips North America Llc | 09/21/2023Open, Classified |
| Z-0278-2024 Class II | DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export…Potential for units suspended on the ceiling to fail and fall. | Philips North America Llc | 09/21/2023Open, Classified |
| Z-0277-2024 Class II | DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export…Potential for units suspended on the ceiling to fail and fall. | Philips North America Llc | 09/21/2023Open, Classified |
| Z-0276-2024 Class II | DigitalDiagnost C90 High Performance, used to acquire, process, store, display and…Potential for units suspended on the ceiling to fail and fall. | Philips North America Llc | 09/21/2023Open, Classified |
| Z-0275-2024 Class II | DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and…Potential for units suspended on the ceiling to fail and fall. | Philips North America Llc | 09/21/2023Open, Classified |
| Z-0274-2024 Class II | DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export…Potential for units suspended on the ceiling to fail and fall. | Philips North America Llc | 09/21/2023Open, Classified |
| Z-0273-2024 Class II | DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export…Potential for units suspended on the ceiling to fail and fall. | Philips North America Llc | 09/21/2023Open, Classified |
| Z-0271-2024 Class II | CombiDiagnost R90, Radiography and Fluoroscopy (R/F) systemPotential for units suspended on the ceiling to fail and fall. | Philips North America Llc | 09/21/2023Open, Classified |
| Z-1589-2023 Class II | CombiDiagnost R90 R1.1Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and… | Philips North America | 03/03/2023Open, Classified |
| Z-1588-2023 Class II | CombiDiagnost R90 R.1.0Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and… | Philips North America | 03/03/2023Open, Classified |
| Z-1587-2023 Class II | ProxiDiagnost N90 R.1.0Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and… | Philips North America | 03/03/2023Open, Classified |
| Z-1001-2023 Class II | AXIOM Luminos AgileThere is potential for the footrest to detach from the patient table during use. | Siemens Medical Solutions USA, Inc | 12/09/2022Open, Classified |
| Z-0119-2023 Class II | ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000Siemens has become aware of three potential software issues with ARTIS pheno systems with software version… | Siemens Medical Solutions USA, Inc | 09/20/2022Open, Classified |
| Z-1294-2022 Class II | Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both… | Siemens Medical Solutions USA, Inc | 06/10/2022Open, Classified |
| Z-1088-2024 Class II | CombiDiagnost R90 1.1 (709031)While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will… | Philips Medical Systems | 02/11/2022Open, Classified |
| Z-1087-2024 Class II | CombiDiagnost R90 1.0 (709030)While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will… | Philips Medical Systems | 02/11/2022Open, Classified |
| Z-0869-2022 Class II | MODEL: X-RAY TV SYSSTEM SONIALVISION safire17It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in… | Shimadzu Medical Systems | 01/10/2022Open, Classified |
| Z-0868-2022 Class II | MODEL: X-RAY TV SYSTEM SONIALVISION G4It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in… | Shimadzu Medical Systems | 01/10/2022Open, Classified |
| Z-0867-2022 Class II | MODEL: X-RAY R/F SYSTEM FLUOROspeed X1It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in… | Shimadzu Medical Systems | 01/10/2022Open, Classified |
| Z-1356-2023 Class II | ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100…If the system experiences an overvoltage / power surge it can cause a short circuit condition within the… | Philips North America Llc | 10/21/2021Open, Classified |
| Z-1355-2023 Class II | CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030…If the system experiences an overvoltage / power surge it can cause a short circuit condition within the… | Philips North America Llc | 10/21/2021Open, Classified |
| Z-0213-2022 Class II | Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model…When the user presses or releases both the APC (accept) button and the Float Tabletop (panning) button at… | Philips North America Llc | 09/24/2021Terminated |
| Z-0241-2022 Class II | CombiDiagnost R90 is multi-functional general R/F systems.The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic… | Philips Healthcare | 09/22/2021Open, Classified |
| Z-1325-2022 Class II | ProxiDiagnost N90. radiography and fluoroscopy systemFollowing a system restart where the Table Height 2 (TH2) is the default setting and then switched to… | Philips Medical Systems DMC GmbH | 05/19/2021Open, Classified |
| Z-1101-2021 Class II | GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System -…GE Healthcare has become aware of a potential safety issue associated with the improper installation of the… | GE Healthcare, LLC | 12/10/2020Terminated |
| Z-0806-2021 Class II | Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector…After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support… | Siemens Medical Solutions USA, Inc | 09/09/2020Terminated |
| Z-0805-2021 Class II | Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector fluoroscopic…After the March 2019 corrective action on the monitor support arm, there is a residual risk of the support… | Siemens Medical Solutions USA, Inc | 09/09/2020Terminated |
| Z-2357-2021 Class II | CombiDiagnost R90 Software Version R1.0 and R1.1Philips has become aware of a software issue, where the kV and mA values are not locked immediately but… | Philips Medical Systems Gmbh, DMC | 07/22/2020Open, Classified |
| Z-2523-2020 Class II | EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic…Thermo switches in the main power supply for the system may be incorrectly installed, resulting in a… | Philips North America, LLC | 06/02/2020Terminated |
| Z-2256-2020 Class II | ProxiDiagnost N90, UDI 706100The thermo switches in the three-phase transformer, which normally aid in powering down the System Power… | Philips North America, LLC | 04/23/2020Terminated |
| Z-2202-2020 Class II | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Type number: 6010/200…Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the… | Agfa N.V. | 04/06/2020Terminated |
| Z-1801-2020 Class II | Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in…No torque was specified for the four screws that connect the gearbox and the mounting flange within the… | Philips North America, LLC | 03/05/2020Terminated |
| Z-2757-2020 Class II | SIEMENS Healthineers Uroskop Omnia max Model: 10762473 - Product Usage: is a device…Two software issues (1) Using the override function in case of blocked system movements affecting Luminos… | Siemens Medical Solutions USA, Inc | 01/08/2020Terminated |
| Z-2756-2020 Class II | SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device…Two software issues (1) Using the override function in case of blocked system movements affecting Luminos… | Siemens Medical Solutions USA, Inc | 01/08/2020Terminated |
| Z-2755-2020 Class II | SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device…Two software issues (1) Using the override function in case of blocked system movements affecting Luminos… | Siemens Medical Solutions USA, Inc | 01/08/2020Terminated |
| Z-1329-2020 Class II | CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system…When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that… | Philips Medical Systems Gmbh, DMC | 12/19/2019Terminated |
| Z-1328-2020 Class II | CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system…When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that… | Philips Medical Systems Gmbh, DMC | 12/19/2019Terminated |
| Z-2056-2019 Class II | AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Product Usage: The…The exposed area of fluo exams possibly does not match the active area of the detector within specified… | Agfa N.V. | 06/27/2019Terminated |