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Panels › Radiology › Product code IZI · Class 2

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)
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Top companies in IZI

DateFirm and productCodeLinked 510(k)
Sep 22, 2010Philips 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
IZIK031333
K033737 +1
Sep 22, 2010Philips 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
IZIK022899
K033737 +1
Sep 22, 2010Philips 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
IZIK022899
Sep 22, 2010Philips 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
IZIK033737
Sep 22, 2010Philips 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
IZIK033737
K984545
Sep 22, 2010Philips 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
IZIK022899
Sep 22, 2010Philips 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
IZIK984545
Sep 22, 2010Philips 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
IZIK984545
Sep 22, 2010Philips 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
IZIK031333
K984545
Aug 16, 2010Siemens Medical Solutions USA, Inc
AXIOM Artis MP/Artis dMP and Artis zee Multipurpose. Angiographic x-ray system.
Terminated
IZIK010721
K021021 +1
Aug 11, 2010Philips 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
IZINone listed
Apr 8, 2010Siemens 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
IZIK021021
Dec 3, 2009Siemens Medical Solutions USA, Inc
Axiom Artis Zee Multi-purpose, Model number 10094139 angiographic x-ray systems
Terminated
IZIK073290
Dec 3, 2009Siemens Medical Solutions USA, Inc
Axiom Artis dMP, Model number 7555365 angiographic x-ray systems
Terminated
IZIK021021
Dec 3, 2009Siemens Medical Solutions USA, Inc
Axiom Artis MP, Model number 5904466 angiographic x-ray systems
Terminated
IZIK010721
Nov 10, 2009Siemens 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
IZIK930635
Nov 10, 2009Siemens 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
IZIK884912
Nov 9, 2009GE 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
IZIK050489
K052157 +2
Sep 24, 2009Philips Medical Systems North America Co. Phillips
Integris Allura Flat Detector 9C
Terminated
IZIK022899
Sep 24, 2009Philips Medical Systems North America Co. Phillips
Allura XPER FD20
Terminated
IZIK033737
Sep 24, 2009Philips Medical Systems North America Co. Phillips
Allura XPER FD20/10
Terminated
IZIK033737
K984545
Sep 24, 2009Philips Medical Systems North America Co. Phillips
Integris XPER FD10 F/C
Terminated
IZIK022899
Sep 24, 2009Philips Medical Systems North America Co. Phillips
Integris BH5000
Terminated
IZIK984545
Sep 24, 2009Philips Medical Systems North America Co. Phillips
Integris H5000F
Terminated
IZIK984545
Sep 24, 2009Philips Medical Systems North America Co. Phillips
Allura XPER 10/10
Terminated
IZIK031333
K984545
Jun 16, 2009Siemens 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
IZIK010721
Jun 16, 2009Siemens 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
IZIK992660
Jun 16, 2009Siemens 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
IZIK930635
Dec 9, 2008Siemens 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
IZIK052202
Dec 9, 2008Siemens 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
IZIK052202
Dec 9, 2008Siemens 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
IZIK052202
Dec 9, 2008Siemens 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
IZIK052202
Dec 9, 2008Siemens 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
IZIK052202
Dec 9, 2008Siemens 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
IZIK052202
Nov 25, 2008Siemens Medical Solutions USA, Inc
Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392.
Terminated
IZIK010721
K021021
Nov 25, 2008Siemens Medical Solutions USA, Inc
Axiom Artis dMP, Axiom Artis Modular Angiography X-Ray System, Model number 7555365.
Terminated
IZIK010721
K021021
Nov 25, 2008Siemens Medical Solutions USA, Inc
Axiom Artis dFA, Axiom Artis Modular Angiography X-Ray System, Model number 7555373.
Terminated
IZIK010721
K021021
Nov 25, 2008Siemens Medical Solutions USA, Inc
Axiom Artis dFC-M, Axiom Artis Modular Angiography X-Ray System, Model number 7727717.
Terminated
IZIK010721
K021021
Nov 25, 2008Siemens Medical Solutions USA, Inc
Axiom Artis dBA, Axiom Artis Modular Angiography X-Ray System, Model number 7555357.
Terminated
IZIK010721
K021021
Nov 25, 2008Siemens Medical Solutions USA, Inc
Axiom Artis dTC, Axiom Artis Modular Angiography X-Ray System, Model number 7413078.
Terminated
IZIK010721
K021021
Nov 25, 2008Siemens Medical Solutions USA, Inc
Axiom Artis dTA, Axiom Artis Modular Angiography X-Ray System, Model number 7008605.
Terminated
IZIK010721
K021021
Nov 25, 2008Siemens Medical Solutions USA, Inc
Axiom Artis dBC-M, Axiom Artis Modular Angiography X-Ray System, Model number 5917054.
Terminated
IZIK010721
K021021
Nov 25, 2008Siemens Medical Solutions USA, Inc
Axiom Artis dFC, Axiom Artis Modular Angiography X-Ray System, Model number 7412807.
Terminated
IZIK010721
K021021
Nov 4, 2008Siemens Medical Solutions USA, Inc
Axiom Artis Zee. Angiographic X-ray System.
Terminated
IZIK073290
Nov 4, 2008Siemens Medical Solutions USA, Inc
AXIOM Artis. Angiographic X-ray System.
Terminated
IZIK010721
Nov 4, 2008Siemens Medical Solutions USA, Inc
NEUROSTAR TOP X-Ray System, Model numbers 6258425 and 6379668.
Terminated
IZIK930635
Nov 4, 2008Siemens Medical Solutions USA, Inc
NEUROSTAR X-Ray System, Model number 6134741.
Terminated
IZIK930635
Nov 4, 2008Siemens Medical Solutions USA, Inc
BICOR TOP X-Ray System, Model number 6134816.
Terminated
IZIK940484
Nov 4, 2008Siemens Medical Solutions USA, Inc
BICOR POLYDOROS X-Ray System, Model number 6134667.
Terminated
IZIK940484
Nov 4, 2008Siemens Medical Solutions USA, Inc
COROSKOP HS-ACS X-Ray System, Model number 6134659.
Terminated
IZIK940484

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