System, X-Ray, Angiographic
FDA product code IZI · Class II (moderate risk) · 21 CFR 892.1600 · Radiology
199510(k) clearances
0PMA approvals
229recalls
Manufacturers
- Siemens Medical Solutions USA, Inc. 13
- GE Medical Systems, LLC 10
- Xre Corp. 10
- Philips Medical Systems North America, Inc. 9
- Novadaq Technologies, Inc. 9
- Shimadzu Precision Instruments, Inc. 8
- Shimadzu Medical Systems 8
- Paieon, Inc. 7
- Philips Medical Systems 6
- Shimadzu Corp. 6
- Siemens Gammasonics, Inc. 5
- Siemens Corp. 4
- Fischer Imaging Corp. 4
- Medis Medical Imaging Systems BV 4
- General Electric Co. 4
- Heartware Intl. Corp. 3
- Camtronics, Ltd. 3
- Pie Medical Imaging BV 3
- Perkins Mfg. Co. 3
- Leica Microsystems (Schweiz) AG 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemIZI · Traditional | Stryker Endoscopy | 05/28/2026SE |
| K253181 | SURGIMAGE SIM 1000H Fluorescence Imaging PlatformIZI · Traditional | Surgimage Corporation | 05/13/2026SE |
| K243645 | IC-Flow Imaging System 2.0IZI · Traditional | Diagnostic Green GmbH | 09/22/2025SE |
| K243077 | Affirm 800IZI · Traditional | Digital Surgery Systems, Inc. (D.B.A True… | 06/27/2025SE |
| K231986 | Modus IRIZI · Traditional | Synaptive Medical, Inc. | 03/25/2024SE |
| K234090 | EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)IZI · Traditional | Surgvision GmbH | 03/20/2024SE |
| K231075 | Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)IZI · Traditional | Carl Zeiss Meditec, Inc. | 06/20/2023SE |
| K230727 | SPY Portable Handheld Imaging (SPY-PHI) SystemIZI · Traditional | Novadaq Technologies Ulc (A Part of Stryker) | 06/05/2023SE |
| K222240 | Explorer Air® IIIZI · Traditional | Surgvision GmbH | 02/28/2023SE |
| K214097 | Explorer Air IIIZI · Traditional | Surgvision GmbH | 02/25/2022SE |
| K202391 | Dir 800IZI · Traditional | Aesculap, Inc. | 01/21/2021SE |
| K192761 | Asimov-MKS Imaging SystemIZI · Traditional | Onlume, Inc. | 01/17/2020SE |
| K190772 | SURGICAL MICROSCOPE SYSTEM ORBEYE with IRIZI · Traditional | Olympus Medical Systems Corp. | 10/10/2019SE |
| K182907 | SPY Elite Intraoperative Perfusion Assessment SystemIZI · Traditional | Novadaq Technologies Ulc. (Now A Part of Stryker) | 01/23/2019SE |
| K181537 | GLOW800IZI · Traditional | Leica Microsystems (Schweiz) AG | 09/07/2018SE |
| K180019 | CAAS WorkstationIZI · Traditional | Pie Medical Imaging BV | 05/03/2018SE |
| K162991 | YELLOW 560 Fluorescence ModuleIZI · Traditional | Carl Zeiss Meditec, AG | 07/24/2017SESD |
| K170239 | Leica FL560IZI · Traditional | Leica Microsystems (Schweiz) AG | 07/05/2017SEKD |
| K151780 | CAAS WorkstationIZI · Traditional | Pie Medical Imaging BV | 03/11/2016SE |
| K141136 | Leica FL800IZI · Traditional | Leica Biosystems Richmond | 08/19/2014SE |
| K133719 | Pde-NeoIZI · Traditional | Hamamatsu Photonics K.K. | 03/27/2014SE |
| K133993 | Caas WorkstationIZI · Traditional | Pie Medical Imaging | 03/25/2014SE |
| K130003 | Xiralite Flourescence Imaging System X4IZI · Traditional | Mivenion GmbH | 01/31/2014SE |
| K130842 | Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura…IZI · Traditional | Philips Medical Systems Nederland B.V. | 05/21/2013SE |
| K113594 | C-Thv SystemIZI · Traditional | Paieon, Inc. | 03/02/2012SE |
| K113034 | GE Innova Solid State Xray Imager Flurosopic X Ray SystemIZI · Traditional | GE Healthcare | 12/13/2011SE |
| K111209 | Integrated Innova - S5I System OptionIZI · Traditional | GE Healthcare | 07/26/2011SE |
| K110256 | The Ic-Pro SystemIZI · Traditional | Paieon, Inc. | 05/27/2011SE |
| K100371 | Spy Intra-Operative Imaging SystemIZI · Traditional | Novadaq Technologies, Inc. | 02/04/2011SE |
| K100849 | Sync-Rx System, Model AS00010IZI · Traditional | Sync-Rx, Ltd. | 05/21/2010SE |
| K100468 | Zeiss Infrared 800 with Flow 800 OptionIZI · Traditional | Carl Zeiss Surgical GmbH | 03/03/2010SE |
| K090745 | Artis Zee / Zeegos with SW VC14IZI · Traditional | Siemens Medical Solutions USA, Inc. | 06/18/2009SE |
| K083745 | The Ic-Pro System, Model Version 3.2IZI · Traditional | Paieon, Inc. | 02/17/2009SE |
| K082907 | Ic-Pro System, Version 3.1.0.4IZI · Traditional | Paieon, Inc. | 11/18/2008SE |
| K073328 | Cardiop-B System, Version 2.1 with LvaIZI · Traditional | Paieon, Inc. | 09/09/2008SE |
| K080612 | Leica FL800IZI · Traditional | Leica Microsystems (Schweiz) AG | 05/09/2008SE |
| K073290 | Artis Zee and ZeegoIZI · Traditional | Siemens Medical Solutions USA, Inc. | 02/11/2008SE |
| K073130 | Spy Fluorescent Imaging SystemIZI · Traditional | Novadaq Technologies, Inc. | 01/10/2008SE |
| K073088 | Spy Fluorescent Imaging SystemIZI · Traditional | Novadaq Technologies, Inc. | 01/10/2008SE |
| K071619 | Spy Fluorescent Imaging SystemIZI · Traditional | Novadaq Technologies, Inc. | 11/09/2007SE |
| K072591 | Cardiop-B System, Version 2.1IZI · Special | Paieon, Inc. | 10/10/2007SE |
| K072222 | Spy Fluorescent Imaging SystemIZI · Special | Novadaq Technologies, Inc. | 09/07/2007SE |
| K072006 | DAR-9400FIZI · Abbreviated | Shimadzu Corp. | 08/31/2007SE |
| K071717 | GE Oec AltitudeIZI · Traditional | Shimadzu Corp. | 07/05/2007SE |
| K071037 | Spy Intra-Operative Imaging System, Model SP2000IZI · Special | Novadaq Technologies, Inc. | 05/10/2007SE |
| K063345 | Spy Imaging SystemIZI · Traditional | Novadaq Technologies, Inc. | 01/12/2007SE |
| K062360 | Bransist SafireIZI · Abbreviated | Shimadzu Corp. | 10/05/2006SE |
| K061871 | Leica Model FL800IZI · Traditional | Leica Microsystems, Inc. | 09/20/2006SE |
| K060867 | Spy Intraoperative Imaging SystemIZI · Traditional | Novadaq Technologies, Inc. | 05/03/2006SE |
| K060749 | XperctIZI · Traditional | Philips Medical Systems North America Co. | 04/04/2006SE |
| K052500 | DAR-8000FIZI · Abbreviated | Shimadzu Medical Systems | 10/17/2005SE |
| K052076 | DAR-8000IIZI · Abbreviated | Shimadzu Medical Systems | 09/02/2005SE |
| K052039 | GE Oec AltitudeIZI · Abbreviated | Ge Oec Medical Systems | 08/11/2005SE |
| K042961 | Spy Intra-Operative Imaging System: SP2000IZI · Traditional | Novadaq Technologies, Inc. | 01/19/2005SE |
| K042646 | DynactIZI · Special | Siemens Medical Systems, Inc. | 10/19/2004SE |
| K041949 | Allura Xper FD10IZI · Traditional | Philips Medical Systems North America Co. | 07/30/2004SE |
| K041027 | Digital Radiography System with Flat Panel Detector, Model DFP8000DIZI · Traditional | Toshibamedical Systems Corporation | 05/14/2004SE |
| K030139 | The Cardiop-B SystemIZI · Traditional | Paieon, Inc. | 04/02/2004SE |
| K032443 | Digital Angiography System Digitex SafireIZI · Abbreviated | Shimadzu Corp. | 02/20/2004SE |
| K033184 | Lateral Angiographic C-Arm Support MH-400IZI · Traditional | Shimadzu Corp. | 12/09/2003SE |
| K031333 | Philips Integris Allura Flat Detector Release 1.2IZI · Traditional | Philips Medical Systems North America, Inc. | 05/13/2003SE |
| K023970 | Quantitative Vascular Angiography - CMSIZI · Traditional | Medis Medical Imaging Systems BV | 01/24/2003SE |
| K023441 | Philips Multidiagnost ElevaIZI · Traditional | Philips Medical Systems | 10/30/2002SE |
| K010721 | Axiom Artis Modular Angiography SystemIZI · Traditional | Siemens Medical Corp. | 03/30/2001SE |
| K010391 | Atlas Multi-Purpose Dsa SystemIZI · Traditional | Cares Built, Inc. | 03/12/2001SE |
| K002840 | Marks Reference Phantom, Measure Reference PhantomIZI · Traditional | The Phantom Laboratory, Inc. | 11/17/2000SE |
| K993947 | Koordinant Angiographic and Operating Room Model X-Ray Table FamilyIZI · Traditional | Siemens Corp. | 12/21/1999SE |
| K993765 | Quantitative Analysis of Left Ventricular Angiograms (QLV)IZI · Special | Medis Medical Imaging Systems BV | 11/26/1999SE |
| K993763 | Quantitative Analysis of Coronary Angiograms (Qca)IZI · Special | Medis Medical Imaging Systems BV | 11/26/1999SE |
| K991922 | Digital Imaging System (BSR)IZI · Traditional | Siemens Medical Solutions USA, Inc. | 09/01/1999SE |
| K991231 | Hitachi VersiflexIZI · Traditional | Hitachi Medical Systems America, Inc. | 05/24/1999SE |
| K984545 | Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) SystemsIZI · Traditional | Philips Medical Systems North America, Inc. | 02/25/1999SE |
| K983877 | Philips Integris 3D Ra OptionIZI · Traditional | Philips Medical Systems North America, Inc. | 12/21/1998SE |
| K982203 | Caas II Lva Biplane OptionIZI · Traditional | Pie Medical Equipment B.V. | 07/14/1998SE |
| K974679 | The Tcs-Medcon's Telecardiology SystemIZI · Traditional | Medcon , Ltd. | 03/23/1998SE |
| K974367 | Advantx LCN, Advantx LCLPIZI · Traditional | GE Medical Systems | 02/13/1998SE |
| K973270 | Leg'Map OptionIZI · Traditional | Ge Medical Systems, Inc. | 11/25/1997SE |
| K973482 | Philips Integris V5000 and BV5000IZI · Traditional | Philips Medical Systems North America, Inc. | 11/10/1997SE |
| K972655 | Control SyringeIZI · Traditional | Medical Specialties Intl., Inc. | 11/04/1997SE |
| K973368 | Strait'Map OptionIZI · Traditional | Ge Medical Systems, Inc. | 10/17/1997SE |
| K972229 | Imageview Coronary Angiography Display and Review SystemIZI · Traditional | Heartware, Inc. | 10/16/1997SE |
| K973342 | DAR-3000BIZI · Traditional | Shimadzu Corp. | 10/08/1997SE |
| K971176 | View Archiving StationIZI · Traditional | Electromed Intl., Ltd. | 09/03/1997SE |
| K971181 | The Midview-Medcon's Dicom ViewerIZI · Traditional | Medcon , Ltd. | 07/29/1997SE |
| K971489 | Ratational Angiography Option for Philips Multidiagnost 4IZI · Traditional | Philips Medical Systems North America, Inc. | 07/03/1997SE |
| K972136 | TV Monitor (P12/17)IZI · Traditional | Perkins Mfg. Co. | 06/26/1997SE |
| K971365 | Philips Integris H5000IZI · Traditional | Philips Medical Systems North America, Inc. | 05/14/1997SE |
| K970738 | Kodak Digital Science Cardiac Digital Acquisition UnitIZI · Traditional | Jamieson Film Co. | 05/07/1997SE |
| K970525 | StatnetIZI · Traditional | Gorca Systems, Inc. | 04/16/1997SE |
| K955179 | Contrast Media SetIZI · Traditional | B.Braun Medical, Inc. | 03/12/1997SE |
| K961451 | DicomnetIZI · Traditional | Lockheed Martin Communications Systems | 07/03/1996SE |
| K955519 | Analytical Review StationIZI · Traditional | Camtronics, Ltd. | 05/09/1996SE |
| K960575 | Advantx Lcv+IZI · Traditional | GE Medical Systems | 05/07/1996SE |
| K954581 | Arc SeriesIZI · Traditional | Continental X-Ray Corp. | 12/21/1995SE |
| K955395 | DAR-2400-15B/30BIZI · Traditional | Shimadzu Medical Systems | 12/11/1995SE |
| K945400 | Hitachi Dynamic 3D Imaging SYSTEM,SF-VA100IZI · Traditional | Hitachi Medical Corp. of America | 11/20/1995SE |
| K954309 | AngiorexIZI · Traditional | Toshiba Medical Systems | 10/06/1995SE |
| K953563 | Vanguard XR-350 Cineangiogram ProjectorIZI · Traditional | Jamieson Film Co. | 10/05/1995SE |
| K952704 | Philips EasyvisionIZI · Traditional | Philips Medical Systems, Inc. | 07/03/1995SE |
| K945540 | Caas IIIZI · Traditional | Pie Medical Equipment B.V. | 06/28/1995SE |
| K946378 | BCM 400CPIZI · Traditional | B C Medical , Ltd. | 05/04/1995SE |
| K945449 | Unicath Llu Angiographic SystemIZI · Traditional | Xre Corp. | 02/27/1995SE |
| K944952 | Angiographic SystemIZI · Traditional | Acoma Medical Imaging, Inc. | 02/17/1995SE |
| K943545 | Ceiling Suspended C-Arm Support MH-100IZI · Traditional | Shimadzu Medical Systems | 02/03/1995SE |
| K945459 | DLXIZI · Traditional | General Electric Co. | 01/30/1995SE |
| K945375 | Advantx LcaIZI · Traditional | GE Medical Systems | 01/30/1995SE |
| K945293 | Top Acom StationIZI · Traditional | Siemens Medical Solutions USA, Inc. | 01/05/1995SE |
| K945483 | CompasIZI · Traditional | General Electric Co. | 12/09/1994SE |
| K943355 | GemnetIZI · Traditional | GE Medical Systems | 11/07/1994SE |
| K940172 | Cardiovascular Measurement System-CmsIZI · Traditional | Medis Medical Imaging Systems, Inc. | 09/29/1994SE |
| K936002 | Cinemac QasIZI · Traditional | Xre Corp. | 09/09/1994SE |
| K935026 | Digital Media Converter (D-Mc)IZI · Traditional | Eigen Video | 08/24/1994SE |
| K941979 | Video Plus with Analytical WorkstationIZI · Traditional | Camtronics, Ltd. | 08/17/1994SE |
| K942503 | Unicath FamilyIZI · Traditional | Angiographic Devices Corp. | 07/20/1994SE |
| K942120 | Advantage Windows Diagnostic X-Ray WorkstationIZI · Traditional | GE Medical Systems | 07/18/1994SE |
| K941177 | Angiorex CAS-05AIZI · Traditional | Toshiba America Medical Systems, In.C | 06/06/1994SE |
| K941946 | Lca Angiographic Imaging SystemIZI · Traditional | GE Medical Systems | 05/20/1994SE |
| K940484 | Coroskop Hi-P Angiographic X-Ray SystemIZI · Traditional | Siemens Medical Solutions USA, Inc. | 04/19/1994SE |
| K933460 | DVFX, Model M256IZI · Traditional | Xre Corp. | 04/07/1994SE |
| K933664 | Polytron T.O.P. (Time, Operation, Performance)IZI · Traditional | Siemens Gammasonics, Inc. | 12/15/1993SE |
| K934496 | X-Ray Angiographic SystemIZI · Traditional | Camtronics, Ltd. | 12/13/1993SE |
| K932410 | Heartview(R) Coronary Angiograph Diagram/Report SyIZI · Traditional | Heartware Intl. Corp. | 12/13/1993SE |
| K931184 | Multi-View Processor (MVP)IZI · Traditional | Adac Laboratories | 11/02/1993SE |
| K933073 | Hearttrace Left Ventricular Analysis SoftwareIZI · Traditional | Heartware Intl. Corp. | 10/07/1993SE |
| K933058 | Hearttrack Quantitative Coronary Angiography SoftwIZI · Traditional | Heartware Intl. Corp. | 09/28/1993SE |
| K930635 | Multistar D Angiographic X-Ray SystemIZI · Traditional | Siemens Medical Solutions USA, Inc. | 09/07/1993SE |
| K931170 | Sony Cardiac Analysis and Review Station (Cars)IZI · Traditional | Sony Medical Systems | 06/14/1993SE |
| K926258 | DLXIZI · Traditional | GE Medical Systems | 03/15/1993SE |
| K925961 | Optima Archival and Retrieval SystemIZI · Traditional | Diagnostic Archives, Inc. | 03/02/1993SE |
| K926082 | Cardiac Stress Table, 056-180/UNIV Roll Stress AttIZI · Traditional | Biodan Medical Systems, Ltd. | 12/30/1992SE |
| K924719 | AncorIZI · Traditional | Siemens Medical Solutions USA, Inc. | 12/30/1992SE |
| K924708 | Cinenet Cardiac Image NetworkIZI · Traditional | Sony Medical Systems | 12/30/1992SE |
| K924137 | Csp-A (Ceiling Suspended Positioner-Angio)IZI · Traditional | Fischer Imaging Corp. | 12/28/1992SE |
| K924828 | Bi-NIZI · Traditional | Xre Corp. | 12/17/1992SE |
| K922222 | Angiographic X-Ray SystemIZI · Traditional | Siemens Medical Solutions USA, Inc. | 12/02/1992SE |
| K923654 | Poly Diagnost CDXIZI · Traditional | Xre Corp. | 11/20/1992SE |
| K923813 | Philips Integris V3000 Rotational Angio FunctionIZI · Traditional | Philips Medical Systems, Inc. | 10/16/1992SE |
| K920862 | BCM-400CIZI · Traditional | B C Medical , Ltd. | 09/30/1992SE |
| K923112 | Angio-BandIZI · Traditional | Cook, Inc. | 09/23/1992SE |
| K922804 | Awos Angiographic WorkstationIZI · Traditional | Siemens Medical Solutions USA, Inc. | 08/28/1992SE |
| K922622 | Philips Cardiac WorkstationIZI · Traditional | Philips Medical Systems, Inc. | 08/11/1992SE |
| K921101 | Philips Integris V3000 FilmIZI · Traditional | Philips Medical Systems, Inc. | 05/15/1992SE |
| K920705 | Polytron Digital Imaging SystemIZI · Traditional | Siemens Medical Solutions USA, Inc. | 04/27/1992SE |
| K920434 | Atlas 2000 Vascular Road Mapping SystemIZI · Traditional | Squires & Assoc., Inc. | 04/13/1992SE |
| K914376 | DXS Digital X-Ray SubtractionIZI · Traditional | Philips Medical Systems (Cleveland), Inc. | 02/04/1992SE |
| K915199 | Storz Imaging SystemIZI · Traditional | Fischer Imaging Corp. | 01/23/1992SE |
| K915232 | Grundig Electronics Various ModelsIZI · Traditional | Perkins Mfg. Co. | 01/09/1992SE |
| K914313 | HicorIZI · Traditional | Siemens Gammasonics, Inc. | 11/27/1991SE |
| K913685 | Unicath Ep.IZI · Traditional | Xre Corp. | 11/07/1991SE |
| K911732 | Advance Disposable Control SyringeIZI · Traditional | Advance Medical Designs, Inc. | 09/16/1991SE |
| K912416 | Angiographic or Fluoroscopic X-Ray SystemIZI · Traditional | Xre Corp. | 08/28/1991SE |
| K913120 | Polystar Angiographic X-Ray SystemIZI · Traditional | Siemens Medical Solutions USA, Inc. | 08/16/1991SE |
| K905518 | Berlex Bolus/Infusion(Tm) Intravenous Admin SetIZI · Traditional | Venusa , Ltd. | 06/21/1991SE |
| K910654 | Cinemeasure (TM)IZI · Traditional | Syracuse Research Corp. | 06/06/1991SE |
| K910370 | Philips Integris V3000 and V4000IZI · Traditional | Philips Medical Systems, Inc. | 05/28/1991SE |
| K905653 | Advantx Afm Angio System S1808IZI · Traditional | GE Medical Systems | 05/15/1991SE |
| K903493 | Namic Contrast Savings Delivery SystemIZI · Traditional | North American Instrument Corp. | 03/26/1991SE |
| K903941 | Shimadzu Digital Subtraction System DAR-2400IZI · Traditional | Shimadzu Medical Systems | 02/04/1991SE |
| K903373 | Catheterization C-Arm Support MH-51C(F)IZI · Traditional | Shimadzu Medical Systems | 11/29/1990SE |
| K903372 | Cath Multidirect Bi-Plane Radio Syst MH-51A/MH-31AIZI · Traditional | Shimadzu Medical Systems | 11/29/1990SE |
| K903371 | Catheterization C-Arm Support MH-51B(F)IZI · Traditional | Shimadzu Medical Systems | 11/29/1990SE |
| K904540 | Video System Interface ModelsIZI · Traditional | Perkins Mfg. Co. | 10/26/1990SE |
| K904447 | Sony Cine Video System SME-3500IZI · Traditional | Sony Medical Electronics Co. | 10/17/1990SE |
| K903375 | HicorIZI · Traditional | Siemens Gammasonics, Inc. | 10/01/1990SE |
| K902542 | Philips Integris C2000 SystemIZI · Traditional | Philips Medical Systems North America, Inc. | 08/17/1990SE |
| K897115 | Angiorex C/N (Angiographic X-Ray System)IZI · Traditional | Toshiba America Medical Systems, In.C | 03/13/1990SE |
| K896088 | Femoral Angiography DrapeIZI · Traditional | Medical Plastics, Inc. | 11/17/1989SE |
| K892849 | Unicath aIZI · Traditional | Xre Corp. | 08/09/1989SE |
| K890348 | LC, Cardiac Positioner #B5078AIZI · Traditional | General Electric Co. | 02/27/1989SE |
| K890352 | MultiskopIZI · Traditional | Siemens Medical Solutions USA, Inc. | 02/22/1989SE |
| K884912 | AngiostarIZI · Traditional | Siemens Medical Solutions USA, Inc. | 02/16/1989SE |
| K884008 | Sony Cine Video System SME-3300IZI · Traditional | Sony Medical Electronics Co. | 11/30/1988SE |
| K883860 | AdvantageIZI · Traditional | Fischer Imaging Corp. | 11/21/1988SE |
| K883831 | ImagerIZI · Traditional | Fischer Imaging Corp. | 11/21/1988SE |
| K880690 | Siemens Pacs/I-AIZI · Traditional | Siemens Gammasonics, Inc. | 10/31/1988SE |
| K882358 | Pulsed Fluoroscopic Control MODEL:PF-02IZI · Traditional | U.S. Imaging, Inc. | 10/19/1988SE |
| K883072 | Digitron 2, Digital Substraction Angio. SystemIZI · Traditional | Siemens Gammasonics, Inc. | 09/14/1988SE |
| K874910 | Shimadzu Digital Subtraction System DAR-200IZI · Traditional | Shimadzu Precision Instruments, Inc. | 07/01/1988SE |
| K875380 | Shimadzu Catheterization C-Arm Stand MH-10IZI · Traditional | Shimadzu Precision Instruments, Inc. | 02/12/1988SE |
| K875379 | Shimadzu Cerebral Angiographic Unit ER-100AIZI · Traditional | Shimadzu Precision Instruments, Inc. | 02/12/1988SE |
| K875376 | Shimadzu Catheterization C-Arm Stand MH-50BIZI · Traditional | Shimadzu Precision Instruments, Inc. | 02/12/1988SE |
| K875375 | Shimadzu Lateral C-Arm MH-30IZI · Traditional | Shimadzu Precision Instruments, Inc. | 02/12/1988SE |
| K875374 | Shimadzu Ceiling-Suspended C-Arm CH-50IZI · Traditional | Shimadzu Precision Instruments, Inc. | 02/12/1988SE |
| K875373 | C-Arm Stand for Biplance Cine Fluorography MH-20IZI · Traditional | Shimadzu Precision Instruments, Inc. | 02/12/1988SE |
| K875372 | Shimadzu Catheterization C-Arm Stand ER-200IZI · Traditional | Shimadzu Precision Instruments, Inc. | 02/12/1988SE |
| K875184 | Unicath LabIZI · Traditional | Xre Corp. | 01/29/1988SE |
| K852331 | Sys, Angiographic, Single-Or Bi-Plane RadiographicIZI · Traditional | Scholten Surgical Instruments, Inc. | 08/01/1986SE |
| K853044 | StericoverIZI · Traditional | Sterimed, Inc. | 11/01/1985SE |
| K850455 | Quantix Cardiac Angiographic SystemIZI · Traditional | Xre Corp. | 05/06/1985SE |
| K842495 | Matrix Video Imager 1020 Compact CamerIZI · Traditional | Matrix Instruments | 08/17/1984SE |
| K842494 | Matris Instru. Video Imager 1010-IZI · Traditional | Matrix Instruments | 08/17/1984SE |
| K834496 | Isorex LS-36IZI · Traditional | Elscint, Inc. | 02/21/1984SE |
| K813588 | CTF Model 9300IZI · Traditional | Thomson-Csf Broadcast, Inc. | 02/04/1982SE |
| K812913 | Omega II Angiographic TableIZI · Traditional | General Electric Co. | 11/24/1981SE |
| K812721 | DigitronIZI · Traditional | Siemens Corp. | 11/04/1981SE |
| K812238 | D.I.V.A.S.IZI · Traditional | Cgr Medical Corp. | 09/11/1981SE |
| K811149 | Pandoros 1200AIZI · Traditional | Siemens Corp. | 06/09/1981SE |
| K810183 | Pro-Top-Angio Shift Table Top ExtensionIZI · Traditional | Philips Medical Systems (Cleveland), Inc. | 02/25/1981SE |
| K781991 | AngioskipIZI · Traditional | Siemens Corp. | 12/07/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2411-2026 Class II | Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for…Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially… | Philips Medical Systems Nederland B.V. | 05/18/2026Open, Classified |
| Z-0654-2022 Class II | Digital Angiography System Bransist safire Generator Model D150GC-40Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography… | Shimadzu Medical Systems | 12/16/2021Open, Classified |
| Z-0556-2021 Class II | MH-200S, system with Ceiling Suspended C-arm Support - Product Usage: intended to be…The firm has identified a problem with the control software for the celling arm of the X-Ray System . This… | Shimadzu Medical Systems | 11/18/2020Open, Classified |
| Z-0554-2021 Class II | Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm…The firm has identified a problem with the control software for the celling arm of the X-Ray System . This… | Shimadzu Medical Systems | 11/18/2020Open, Classified |
| Z-1491-2020 Class II | Poly G Integris H5000, System code 72246A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | Philips North America, LLC | 12/30/2019Terminated |
| Z-1489-2020 Class II | MultiDiagnost Eleva, System codes 722030 722016 722017 708032 708036 708034 708037 708038A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a… | Philips North America, LLC | 12/30/2019Terminated |
| Z-1342-2019 Class II | Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/…In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has… | Siemens Medical Solutions USA, Inc | 04/09/2019Terminated |
| Z-1341-2019 Class II | Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis zee and Q/…In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has… | Siemens Medical Solutions USA, Inc | 04/09/2019Terminated |
| Z-1340-2019 Class II | Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a…In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has… | Siemens Medical Solutions USA, Inc | 04/09/2019Terminated |
| Z-1339-2019 Class II | Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and…In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has… | Siemens Medical Solutions USA, Inc | 04/09/2019Terminated |
| Z-1201-2019 Class II | Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic…There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from… | GE Healthcare, LLC | 03/15/2019Open, Classified |
| Z-1200-2019 Class II | Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic…There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from… | GE Healthcare, LLC | 03/15/2019Open, Classified |
| Z-1199-2019 Class II | Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic…There is a potential for loss of the x-ray imaging function when the user changes field of view (FOV) from… | GE Healthcare, LLC | 03/15/2019Open, Classified |
| Z-1052-2019 Class II | MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I…The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement… | Philips North America, LLC | 02/28/2019Terminated |
| Z-1141-2019 Class II | Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura…Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is… | Philips Medical Systems Nederlands | 02/19/2019Terminated |
| Z-1140-2019 Class II | Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes:…Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is… | Philips Medical Systems Nederlands | 02/19/2019Terminated |
| Z-0959-2019 Class II | BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be…Normal operation of the device is to power up the device in the morning, register the first patient, and… | Shimadzu Medical Systems Usa Com | 01/14/2019Terminated |
| Z-0558-2019 Class II | Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated…This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-ray tube.… | Siemens Medical Solutions USA, Inc | 10/26/2018Terminated |
| Z-0457-2019 Class II | ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product…Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to… | Siemens Medical Solutions USA, Inc | 10/19/2018Terminated |
| Z-3230-2018 Class II | AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3229-2018 Class II | AIIuraXperFDlO, System Code 722010 Vascular, cardiovascular and neurovascular imaging…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3228-2018 Class II | AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovascular imaging…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3227-2018 Class II | Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurovascular imaging…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3226-2018 Class II | AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3225-2018 Class II | Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3224-2018 Class II | Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3223-2018 Class II | Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3222-2018 Class II | Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3221-2018 Class II | Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and neurovascular imaging…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3220-2018 Class II | NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3219-2018 Class II | INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and neurovascular…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3218-2018 Class II | INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascular imaging…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3217-2018 Class II | INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3216-2018 Class II | INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3215-2018 Class II | INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3214-2018 Class II | INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular and…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-3213-2018 Class II | INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging…There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from… | Philips Electronics North America Corporation | 07/16/2018Terminated |
| Z-1605-2018 Class II | MultiDiagnost Eleva 708036 As a multifunctional universal imaging application system…The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will… | Philips Medical Systems Nederlands | 03/26/2018Terminated |
| Z-2060-2018 Class II | Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system…When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the… | Shimadzu Medical Systems | 01/12/2018Terminated |
| Z-0707-2018 Class II | Artis Zee and Zeego, Model Numbers: 10094135, 10094137, 10094141, 10094142, 10094143…Potential for liquid entry | Siemens Medical Solutions USA, Inc | 06/06/2017Terminated |
| Z-1824-2017 Class II | Artis zee, Angiographic x-ray systemSoftware error - As a result of a software fault in Artis zee systems with software version VD11 and an A100… | Siemens Medical Solutions USA, Inc | 03/28/2017Terminated |
| Z-1467-2017 Class II | Artis Zee and Zeego fluoroscopic x-ray systemA gap in the housing of the wireless foot switch could potentially result in liquids penetrating the… | Siemens Medical Solutions USA, Inc | 02/27/2017Terminated |
| Z-2686-2017 Class II | Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography…Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain… | Siemens Medical Solutions USA, Inc | 02/03/2017Terminated |
| Z-1062-2017 Class II | Velara Generator with an old Firmware version used with the Philips Integris BH5000System may lock up. | Philips Electronics North America Corporation | 12/09/2016Terminated |
| Z-1061-2017 Class II | Velara Generator with an old Firmware version used with Philips Allura Xper Systems…System may lock up. | Philips Electronics North America Corporation | 12/09/2016Terminated |
| Z-0923-2017 Class II | Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging…Due to a production error, screws were not tightened to specified torque. These screws may come loose from… | Philips Electronics North America Corporation | 12/01/2016Terminated |
| Z-0908-2017 Class II | ADVANTX LCV+GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… | GE Healthcare, LLC | 11/21/2016Terminated |
| Z-0907-2017 Class II | ADVANTX LCN+GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… | GE Healthcare, LLC | 11/21/2016Terminated |
| Z-0906-2017 Class II | ADVANTX LCLP+GE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… | GE Healthcare, LLC | 11/21/2016Terminated |
| Z-0905-2017 Class II | ADVANTX LCAGE Healthcare is conducting a recall due to the potential fall of aged CRT monitors - Prestige 2, Prestilix… | GE Healthcare, LLC | 11/21/2016Terminated |