System, X-Ray, Angiographic
Regulation 892.1600
2510(k)s in 12 months (199 all time)
1recalls in 12 months (259 all time)
240recalls that name a 510(k)
Top companies in IZI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc BICOR HS X-Ray System, Model number 6005776 Terminated |
IZI | K940484 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc MULTISTAR POLYDOROS X-Ray System, Model number 2845001 Terminated |
IZI | K930635 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc Coroskop C X-Ray System, Model numbers 6005636 and 9108572. Terminated |
IZI | K940484 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc Coroskop Top X-Ray System, Model number 6134808. Terminated |
IZI | K940484 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc MULTISTAR P X-Ray System, Model number 3773004. Terminated |
IZI | K930635 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383. Terminated |
IZI | K940484 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc Bicor X-Ray System, Model number 9023136. Terminated |
IZI | K940484 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc Coroskop X-Ray System, Model numbers 6258219 and 6379759. Terminated |
IZI | K940484 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc MULTISTAR D X-Ray System, Model number 3772501. Terminated |
IZI | K930635 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc ANGIOSTAR Plus X-Ray System, Model number 6379718. Terminated |
IZI | K884912 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc ANGIOSTAR X-Ray System, Model numbers 9359142 and 6379668. Terminated |
IZI | K884912 |
| Sep 16, 2008 | Philips Medical Systems North America Co. Phillips Philips OmniDiagnost Eleva X-Ray System is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. Terminated |
IZI | K032046 |
| Sep 16, 2008 | GE Healthcare Advantx-E is an angiographic X-Ray system. Terminated |
IZI | K945375 K960575 +1 |
| Dec 7, 2007 | Philips Medical Systems North America Co. Phillips Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021 Terminated |
IZI | K033737 |
| Dec 7, 2007 | Philips Medical Systems North America Co. Phillips Allura Xper FD20 X-Ray System, Release 2.2, Philips Medical Systems, Bothell, WA 98021 Terminated |
IZI | K033737 |
| Sep 25, 2007 | Philips Medical Systems North America Co. Phillips Philips Multi Diagnost Eleva Terminated |
IZI | K023441 |
| Sep 25, 2007 | Philips Medical Systems North America Co. Phillips Philips Omni Diagnost Eleva Terminated |
IZI | K032046 |
| Mar 8, 2007 | Siemens Medical Solutions USA, Inc AXIOM Artis MP, Angiographic x-ray system, model number 7555365 Terminated |
IZI | K010721 |
| Mar 8, 2007 | Siemens Medical Solutions USA, Inc AXIOM Artis MP, Angiographic x-ray system, model number 5904466 Terminated |
IZI | K010721 |
| Jan 25, 2007 | Philips Medical Systems North America Co. Phillips FD 20/10 X-Ray System, Angiograph, biplane, digital Allura FD, 10' and 20' detectors Terminated |
IZI | None listed |
| Jan 25, 2007 | Philips Medical Systems North America Co. Phillips FD 10/10 X-Ray System, Angiograph, bi-plane digital Allura FD, 10' detector Terminated |
IZI | K031333 |
| Jan 25, 2007 | Philips Medical Systems North America Co. Phillips Allura FD20 x-ray system, angiograph, monoplane, digital Allura FD with a 20' detector FD Terminated |
IZI | K022899 |
| Jan 25, 2007 | Philips Medical Systems North America Co. Phillips Allura FD 10 FC, X-Ray System, angiographic - a monoplane, digital Allura FD (flat detector) with a 10' Image Intensifier (II). Terminated |
IZI | K022899 |
| Jan 25, 2007 | Philips Medical Systems North America Co. Phillips Allura Mono X-Ray System, angiographic - monoplane, analog Allura with a 12' and 15' Image Intensifier Terminated |
IZI | K984545 |
| Jan 25, 2007 | Philips Medical Systems North America Co. Phillips Philips Integris Allura x-ray systems angiographic - Allura 9 F/C (floor and ceiling models). A mono-plane analog Allura with a 9' Image Intensifier Terminated |
IZI | K002016 |
| Nov 14, 2006 | Philips Medical Systems North America Co. Phillips Allura Xper FD 20/10 x-ray, and fluoroscopy Terminated |
IZI | K033737 |
| Nov 14, 2006 | Philips Medical Systems North America Co. Phillips Allura X-per FD 10/10 x-ray, and fluoroscopy Terminated |
IZI | K031333 |
| Nov 8, 2006 | Philips Medical Systems North America Co. Phillips Allura Xper FD 10 x-ray, angiographic system Terminated |
IZI | K041949 |
| Nov 8, 2006 | Philips Medical Systems North America Co. Phillips Allura Xper FD 10/10 x-ray, angiographic system Terminated |
IZI | K041949 |
| Apr 26, 2006 | Siemens Medical Solutions USA, Inc AXIOM Artis X-ray systems running software versions VB11K and VB22G Terminated |
IZI | None listed |
| Feb 28, 2006 | Philips Medical Systems North America Co. Phillips Allura Xper FD10 x-ray system Terminated |
IZI | K033737 |
| Feb 28, 2006 | Philips Medical Systems North America Co. Phillips Allura Xper FD10/10 x-ray system Terminated |
IZI | K031333 |
| Nov 29, 2005 | Philips Medical Systems North America Co. Phillips AD6 table, modified, used with the XPER systems. The modification on the table is the cables used for connecting to the XPER systems. Terminated |
IZI | K033737 K041949 |
| Nov 29, 2005 | Philips Medical Systems North America Co. Phillips AD5 table, modified, used with the XPER x-ray systems. The modification on the table is the cables used for connecting to the XPER systems. Terminated |
IZI | K033737 K041949 |
| Nov 29, 2005 | Philips Medical Systems North America Co. Phillips AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version. Terminated |
IZI | K002016 K020055 +3 |
| Nov 29, 2005 | Philips Medical Systems North America Co. Phillips AD5 table for use with Integris and Integris Allura x-ray systems Terminated |
IZI | K002016 K020055 +3 |
| Aug 3, 2005 | Argon Medical Devices, Inc Labeling is as follows:
Product labeling:
''***Argon Medical Devices***RE-ORDER NO./REF 193248***12cc Control Syringe***ST/FR/TR/FM w/ Reservoir***This device is designed for the administraion and r Terminated |
IZI | None listed |
| Aug 3, 2005 | Argon Medical Devices, Inc Labeling is as follows:
Product Labeling:
''***Argon Medical Devices***12cc Control Syringe***FR/TR/RM w/ Reservoir***SINGLE USE ONLY***REF/REORDER NO. 093209***This device is designed for the admin Terminated |
IZI | None listed |
| Aug 3, 2005 | Argon Medical Devices, Inc Labeling is as follows:
Product Labeling:
''***Argon Medical Devices***MANIFOLD KIT***SINGLE USE ONLY***REF/REORDER NO. 094337***EtO STERILIZATION RECOMMENDED***Caution: For manufacturing, processi Terminated |
IZI | None listed |
| Aug 3, 2005 | Argon Medical Devices, Inc Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows:
Product Label
''***Argon Medical Device***REORDER NO./REF 193205 Terminated |
IZI | K911732 |
| Aug 3, 2005 | Argon Medical Devices, Inc Labeling is as follows:
Product Labeling:
''***Argon Medical Devices***CUSTOM MANIFOLD KIT***REF/REORDER NO. 194902A***CONTENTS: 1 3-Port Manifold, 500 PSI***1 ASY CDX3 Transducer***1 Stopcock Assy Terminated |
IZI | K911732 |
| Aug 3, 2005 | Argon Medical Devices, Inc Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows:
Product Label
''***Argon Medical Device***10cc Control Syringe F Terminated |
IZI | K911732 |
| May 11, 2005 | Siemens Medical Solutions USA, Inc Axiom Artis MP X-Ray System Terminated |
IZI | K010721 |
| May 3, 2005 | Siemens Medical Solutions USA, Inc Axiom Artis X-Ray System using software version VB11D or VB20B Terminated |
IZI | K010721 |
| Nov 16, 2004 | Siemens Medical Solutions USA, Inc POLYSTAR T.O.P., Angiographic X-Ray System, Model
Numbers 1148902 and 4784505. Terminated |
IZI | K913120 |
| Nov 16, 2004 | Siemens Medical Solutions USA, Inc POLYSTAR, Angiographic X-Ray System, Model 1148902 Terminated |
IZI | K913120 |
| Sep 14, 2004 | Siemens Medical Solutions USA, Inc Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 656 Terminated |
IZI | K010721 |
| Sep 14, 2004 | Siemens Medical Solutions USA, Inc Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649 Terminated |
IZI | K010721 |
| Aug 4, 2004 | Philips Medical Systems Sales & Service Region No. America MultiDiagnost Eleva
Part Numbers: 9896 001 41501 and 9896 001 41502 Terminated |
IZI | None listed |
| Jul 20, 2004 | Siemens Medical Solutions USA, Inc SIEMENS AXIOM Artis - AUTOMAP FUNCTION Terminated |
IZI | K010721 |
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