ClearanceBrief
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)
Nov 4, 2008Siemens Medical Solutions USA, Inc
BICOR HS X-Ray System, Model number 6005776
Terminated
IZIK940484
Nov 4, 2008Siemens Medical Solutions USA, Inc
MULTISTAR POLYDOROS X-Ray System, Model number 2845001
Terminated
IZIK930635
Nov 4, 2008Siemens Medical Solutions USA, Inc
Coroskop C X-Ray System, Model numbers 6005636 and 9108572.
Terminated
IZIK940484
Nov 4, 2008Siemens Medical Solutions USA, Inc
Coroskop Top X-Ray System, Model number 6134808.
Terminated
IZIK940484
Nov 4, 2008Siemens Medical Solutions USA, Inc
MULTISTAR P X-Ray System, Model number 3773004.
Terminated
IZIK930635
Nov 4, 2008Siemens Medical Solutions USA, Inc
Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383.
Terminated
IZIK940484
Nov 4, 2008Siemens Medical Solutions USA, Inc
Bicor X-Ray System, Model number 9023136.
Terminated
IZIK940484
Nov 4, 2008Siemens Medical Solutions USA, Inc
Coroskop X-Ray System, Model numbers 6258219 and 6379759.
Terminated
IZIK940484
Nov 4, 2008Siemens Medical Solutions USA, Inc
MULTISTAR D X-Ray System, Model number 3772501.
Terminated
IZIK930635
Nov 4, 2008Siemens Medical Solutions USA, Inc
ANGIOSTAR Plus X-Ray System, Model number 6379718.
Terminated
IZIK884912
Nov 4, 2008Siemens Medical Solutions USA, Inc
ANGIOSTAR X-Ray System, Model numbers 9359142 and 6379668.
Terminated
IZIK884912
Sep 16, 2008Philips 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
IZIK032046
Sep 16, 2008GE Healthcare
Advantx-E is an angiographic X-Ray system.
Terminated
IZIK945375
K960575 +1
Dec 7, 2007Philips Medical Systems North America Co. Phillips
Allura Xper FD20/10, Release 1.2, Philips Medical Systems, Bothell, WA 98021
Terminated
IZIK033737
Dec 7, 2007Philips Medical Systems North America Co. Phillips
Allura Xper FD20 X-Ray System, Release 2.2, Philips Medical Systems, Bothell, WA 98021
Terminated
IZIK033737
Sep 25, 2007Philips Medical Systems North America Co. Phillips
Philips Multi Diagnost Eleva
Terminated
IZIK023441
Sep 25, 2007Philips Medical Systems North America Co. Phillips
Philips Omni Diagnost Eleva
Terminated
IZIK032046
Mar 8, 2007Siemens Medical Solutions USA, Inc
AXIOM Artis MP, Angiographic x-ray system, model number 7555365
Terminated
IZIK010721
Mar 8, 2007Siemens Medical Solutions USA, Inc
AXIOM Artis MP, Angiographic x-ray system, model number 5904466
Terminated
IZIK010721
Jan 25, 2007Philips Medical Systems North America Co. Phillips
FD 20/10 X-Ray System, Angiograph, biplane, digital Allura FD, 10' and 20' detectors
Terminated
IZINone listed
Jan 25, 2007Philips Medical Systems North America Co. Phillips
FD 10/10 X-Ray System, Angiograph, bi-plane digital Allura FD, 10' detector
Terminated
IZIK031333
Jan 25, 2007Philips Medical Systems North America Co. Phillips
Allura FD20 x-ray system, angiograph, monoplane, digital Allura FD with a 20' detector FD
Terminated
IZIK022899
Jan 25, 2007Philips 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
IZIK022899
Jan 25, 2007Philips Medical Systems North America Co. Phillips
Allura Mono X-Ray System, angiographic - monoplane, analog Allura with a 12' and 15' Image Intensifier
Terminated
IZIK984545
Jan 25, 2007Philips 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
IZIK002016
Nov 14, 2006Philips Medical Systems North America Co. Phillips
Allura Xper FD 20/10 x-ray, and fluoroscopy
Terminated
IZIK033737
Nov 14, 2006Philips Medical Systems North America Co. Phillips
Allura X-per FD 10/10 x-ray, and fluoroscopy
Terminated
IZIK031333
Nov 8, 2006Philips Medical Systems North America Co. Phillips
Allura Xper FD 10 x-ray, angiographic system
Terminated
IZIK041949
Nov 8, 2006Philips Medical Systems North America Co. Phillips
Allura Xper FD 10/10 x-ray, angiographic system
Terminated
IZIK041949
Apr 26, 2006Siemens Medical Solutions USA, Inc
AXIOM Artis X-ray systems running software versions VB11K and VB22G
Terminated
IZINone listed
Feb 28, 2006Philips Medical Systems North America Co. Phillips
Allura Xper FD10 x-ray system
Terminated
IZIK033737
Feb 28, 2006Philips Medical Systems North America Co. Phillips
Allura Xper FD10/10 x-ray system
Terminated
IZIK031333
Nov 29, 2005Philips 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
IZIK033737
K041949
Nov 29, 2005Philips 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
IZIK033737
K041949
Nov 29, 2005Philips 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
IZIK002016
K020055 +3
Nov 29, 2005Philips Medical Systems North America Co. Phillips
AD5 table for use with Integris and Integris Allura x-ray systems
Terminated
IZIK002016
K020055 +3
Aug 3, 2005Argon 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
IZINone listed
Aug 3, 2005Argon 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
IZINone listed
Aug 3, 2005Argon 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
IZINone listed
Aug 3, 2005Argon 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
IZIK911732
Aug 3, 2005Argon 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
IZIK911732
Aug 3, 2005Argon 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
IZIK911732
May 11, 2005Siemens Medical Solutions USA, Inc
Axiom Artis MP X-Ray System
Terminated
IZIK010721
May 3, 2005Siemens Medical Solutions USA, Inc
Axiom Artis X-Ray System using software version VB11D or VB20B
Terminated
IZIK010721
Nov 16, 2004Siemens Medical Solutions USA, Inc
POLYSTAR T.O.P., Angiographic X-Ray System, Model Numbers 1148902 and 4784505.
Terminated
IZIK913120
Nov 16, 2004Siemens Medical Solutions USA, Inc
POLYSTAR, Angiographic X-Ray System, Model 1148902
Terminated
IZIK913120
Sep 14, 2004Siemens Medical Solutions USA, Inc
Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 656
Terminated
IZIK010721
Sep 14, 2004Siemens Medical Solutions USA, Inc
Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649
Terminated
IZIK010721
Aug 4, 2004Philips Medical Systems Sales & Service Region No. America
MultiDiagnost Eleva Part Numbers: 9896 001 41501 and 9896 001 41502
Terminated
IZINone listed
Jul 20, 2004Siemens Medical Solutions USA, Inc
SIEMENS AXIOM Artis - AUTOMAP FUNCTION
Terminated
IZIK010721

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