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) |
|---|---|---|---|
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5000, and Integris Allura 12-15 Biplane.
The BIPLANE system has two C-arms and it allows the operator to im Terminated |
IZI | K031333 K033737 +1 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips MONOPLANE X-ray Imaging Systems include the Allura XPER FD10 F/C, Allura XPER FD20, Integris H5000/Allura 9 F/C, Integris CV, and Allura 12-15 Monoplane.
The Monoplane system has one C-arm and it c Terminated |
IZI | K022899 K033737 +1 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Integris Allura Flat Detector 9C Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 PRODUCTS 6501 * (number located on the generator cabine Terminated |
IZI | K022899 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Allura XPER FD20 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 PRODUCTS 6501 * (number located on the generator cabinet).
Intended use Terminated |
IZI | K033737 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Allura XPER FD 20/10 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet).
Intended use for Terminated |
IZI | K033737 K984545 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Integris XPER FD10 F/C Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet).
Intended use fo Terminated |
IZI | K022899 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Integris BH5000 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet).
Intended use for Angio Terminated |
IZI | K984545 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Integris H5000F Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet).
Intended use for Angio Terminated |
IZI | K984545 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips Allura XPER 10/10 Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 6501 * (number located on the generator cabinet).
Intended use for Ang Terminated |
IZI | K031333 K984545 |
| Aug 16, 2010 | Siemens Medical Solutions USA, Inc AXIOM Artis MP/Artis dMP and Artis zee Multipurpose. Angiographic x-ray system. Terminated |
IZI | K010721 K021021 +1 |
| Aug 11, 2010 | Philips Medical Systems North America Co. Phillips Motorized Height Ceiling Suspensions (MCS) and motorized height movement (actuator) for X-ray systems.
Usage: Ceiling suspension unit with an actuator to hold monitors and X-ray shields. Terminated |
IZI | None listed |
| Apr 8, 2010 | Siemens Medical Solutions USA, Inc Axiom Artis Systems Operating with VB22, VB23, VB30, and VB31. Model number 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, and 7728392.
Intended use: Angiographic x-ray system. Terminated |
IZI | K021021 |
| Dec 3, 2009 | Siemens Medical Solutions USA, Inc Axiom Artis Zee Multi-purpose, Model number 10094139
angiographic x-ray systems Terminated |
IZI | K073290 |
| Dec 3, 2009 | Siemens Medical Solutions USA, Inc Axiom Artis dMP, Model number 7555365
angiographic x-ray systems Terminated |
IZI | K021021 |
| Dec 3, 2009 | Siemens Medical Solutions USA, Inc Axiom Artis MP, Model number 5904466
angiographic x-ray systems Terminated |
IZI | K010721 |
| Nov 10, 2009 | Siemens Medical Solutions USA, Inc Koodinat M/MP Patient Table used with Multistar Model 6239003.
The device is used as an Angiographic X-Ray System. Terminated |
IZI | K930635 |
| Nov 10, 2009 | Siemens Medical Solutions USA, Inc Koodinat M/MP Patient Table used with Angiostar Model 5294009.
The device is used as an Angiographic X-Ray System. Terminated |
IZI | K884912 |
| Nov 9, 2009 | GE Medical Systems, LLC GE Healthcare, GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Terminated |
IZI | K050489 K052157 +2 |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Integris Allura Flat Detector 9C Terminated |
IZI | K022899 |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Allura XPER FD20 Terminated |
IZI | K033737 |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Allura XPER FD20/10 Terminated |
IZI | K033737 K984545 |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Integris XPER FD10 F/C Terminated |
IZI | K022899 |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Integris BH5000 Terminated |
IZI | K984545 |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Integris H5000F Terminated |
IZI | K984545 |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Allura XPER 10/10 Terminated |
IZI | K031333 K984545 |
| Jun 16, 2009 | Siemens Medical Solutions USA, Inc Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 7559375 Upper Body radiation shield, Artis T. Terminated |
IZI | K010721 |
| Jun 16, 2009 | Siemens Medical Solutions USA, Inc Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 4787714 Upper Body radiation shield, Artis floor. Terminated |
IZI | K992660 |
| Jun 16, 2009 | Siemens Medical Solutions USA, Inc Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 7721165 Upper Body radiation shield, fixed. Terminated |
IZI | K930635 |
| Dec 9, 2008 | Siemens Medical Solutions USA, Inc AXIOM Artis System dMP using software version VB31D with 30x40 cm2 flat detectors.
AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedure Terminated |
IZI | K052202 |
| Dec 9, 2008 | Siemens Medical Solutions USA, Inc AXIOM Artis System dTA using software version VB31D with 30x40 cm2 flat detectors.
AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedure Terminated |
IZI | K052202 |
| Dec 9, 2008 | Siemens Medical Solutions USA, Inc AXIOM Artis System dTC using software version VB31D with 30x40 cm2 flat detectors.
AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedure Terminated |
IZI | K052202 |
| Dec 9, 2008 | Siemens Medical Solutions USA, Inc AXIOM Artis System dFA using software version VB31D with 30x40 cm2 flat detectors.
AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedure Terminated |
IZI | K052202 |
| Dec 9, 2008 | Siemens Medical Solutions USA, Inc AXIOM Artis System dBA using software version VB31D with 30x40 cm2 flat detectors.
AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedure Terminated |
IZI | K052202 |
| Dec 9, 2008 | Siemens Medical Solutions USA, Inc AXIOM Artis System dFC using software version VB31D with 30x40 cm2 flat detectors.
AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedure Terminated |
IZI | K052202 |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392. Terminated |
IZI | K010721 K021021 |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dMP, Axiom Artis Modular Angiography X-Ray System, Model number 7555365. Terminated |
IZI | K010721 K021021 |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dFA, Axiom Artis Modular Angiography X-Ray System, Model number 7555373. Terminated |
IZI | K010721 K021021 |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dFC-M, Axiom Artis Modular Angiography X-Ray System, Model number 7727717. Terminated |
IZI | K010721 K021021 |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dBA, Axiom Artis Modular Angiography X-Ray System, Model number 7555357. Terminated |
IZI | K010721 K021021 |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dTC, Axiom Artis Modular Angiography X-Ray System, Model number 7413078. Terminated |
IZI | K010721 K021021 |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dTA, Axiom Artis Modular Angiography X-Ray System, Model number 7008605. Terminated |
IZI | K010721 K021021 |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dBC-M, Axiom Artis Modular Angiography X-Ray System, Model number 5917054. Terminated |
IZI | K010721 K021021 |
| Nov 25, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis dFC, Axiom Artis Modular Angiography X-Ray System, Model number 7412807. Terminated |
IZI | K010721 K021021 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc Axiom Artis Zee. Angiographic X-ray System. Terminated |
IZI | K073290 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc AXIOM Artis. Angiographic X-ray System. Terminated |
IZI | K010721 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc NEUROSTAR TOP X-Ray System, Model numbers 6258425 and 6379668. Terminated |
IZI | K930635 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc NEUROSTAR X-Ray System, Model number 6134741. Terminated |
IZI | K930635 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc BICOR TOP X-Ray System, Model number 6134816. Terminated |
IZI | K940484 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc BICOR POLYDOROS X-Ray System, Model number 6134667. Terminated |
IZI | K940484 |
| Nov 4, 2008 | Siemens Medical Solutions USA, Inc COROSKOP HS-ACS X-Ray System, Model number 6134659. Terminated |
IZI | K940484 |
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