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)
Get daily alerts for IZISample briefCSV

Top companies in IZI

DateFirm and productCodeLinked 510(k)
Dec 16, 2014GE Healthcare, LLC
Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and
Terminated
IZIK122457
Dec 1, 2014Novadaq Technologies, Inc.
Non-sterile drape
Terminated
IZIK071619
Dec 1, 2014Novadaq Technologies, Inc.
LUNA Chest, Model No. LU4006
Terminated
IZIK071619
Dec 1, 2014Siemens Medical Solutions USA, Inc
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
Terminated
IZIK073290
Nov 7, 2014Siemens Medical Solutions USA, Inc
Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedu
Terminated
IZIK073290
Sep 24, 2014Philips Medical Systems, Inc.
Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper
Terminated
IZIK031333
K033737 +3
Sep 24, 2014Siemens Medical Solutions USA, Inc
AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures in
Terminated
IZIK010721
K073290
Sep 22, 2014Siemens Medical Solutions USA, Inc
Artis zee and Artis zeego systems. x-ray, angiographic system
Terminated
IZIK073290
May 8, 2014Shimadzu Medical Systems
Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.
Terminated
IZIK052500
Mar 31, 2014Siemens Medical Solutions USA, Inc
Artis Zee Angiographic x-ray systems.
Terminated
IZIK073290
Mar 22, 2014Siemens Medical Solutions USA, Inc
AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited
Terminated
IZIK073290
Feb 24, 2014Siemens Medical Solutions USA, Inc
Siemens Artis zee Ceiling Systems. Angiographic x-ray system.
Terminated
IZIK073290
Jan 28, 2014GE Healthcare, LLC
GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in
Terminated
IZIK122457
Nov 14, 2013Siemens Medical Solutions USA, Inc
Artis zee systems x-ray, angiographic system
Terminated
IZIK090745
Aug 28, 2013Siemens Medical Solutions USA, Inc
Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system.
Terminated
IZIK021021
Aug 9, 2013Siemens Medical Solutions USA, Inc
Siemens AXIOM Artis zeego x-ray, angiographic system
Terminated
IZIK090745
Jul 22, 2013Siemens Medical Solutions USA, Inc
ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system
Terminated
IZIK073290
K090745
Jul 17, 2013Siemens Medical Solutions USA, Inc
Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system
Terminated
IZIK090745
Mar 26, 2013Siemens Medical Solutions USA, Inc
Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system
Terminated
IZIK073290
K090745
Mar 25, 2013Siemens Medical Solutions USA, Inc
Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system
Terminated
IZIK090745
Oct 17, 2012GE Healthcare, LLC
GE Healthcare innova 3131-IQ Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional
Terminated
IZINone listed
Oct 17, 2012GE Healthcare, LLC
GE Healthcare innova 3100-IQ, Mobile X-ray system The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional p
Terminated
IZINone listed
Oct 17, 2012GE Healthcare, LLC
GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional pr
Terminated
IZINone listed
Jun 20, 2012Philips Healthcare Inc.
Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva
Terminated
IZIK023441
K050151
Apr 25, 2012Philips Healthcare Inc.
Allura X-ray System. The Allura X-ray System is an angiographic X-ray system.
Terminated
IZIK031333
K033737
Mar 29, 2012Philips Healthcare Inc.
Philips Healthcare MD Eleva system. Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional applications
Terminated
IZINone listed
Mar 19, 2012GE Healthcare, LLC
GE Healthcare Innova X-ray Imaging Systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to r
Terminated
IZINone listed
Mar 9, 2012Philips Medical Systems Nederlands
Philips MultiDiagnost Eleva FD, Software R5.1.x Model: 708034 Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal system. General R/F. Fluoroscopy, Radiography
Terminated
IZIK023441
Mar 9, 2012Philips Medical Systems Nederlands
Philips MultiDiagnost Eleva II Software Version R4.1.x Model: 708032 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional I universal system. General R/F. Fluoroscopy,
Terminated
IZIK023441
Feb 8, 2012Philips Healthcare Inc.
MultiDiagnost Eleva IITV (MD-EII) with Software Release: PBL 6.1.1 Product Code 708036 Product Usage: The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal sy
Terminated
IZIK023441
Feb 2, 2012Philips Healthcare Inc.
Philips MultiDiagnost Eleva FD Software release: PBL 6.1.1 Product Code 708037 Product Usage: The Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/universal system. Ge
Terminated
IZIK050151
Aug 10, 2011Philips Healthcare Inc.
Allura Xper Systems Models: Allura Xper FD10 (F/C)-Biplane Fixed Allura Xper FD10/10 (incl. OR table) Allura Xper FD20- High resolution fixed-x ray Allura Xper FD20/10 Allura Xper FD20/20 Allura CV20
Terminated
IZIK031333
K033737 +1
Mar 22, 2011Philips Medical Systems North America Co. Phillips
Allura XPER FD 20 and and Allura CV20; Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura CV20. Angiographic X-ray systems with a solid state X-ray imaging device for c
Terminated
IZINone listed
Mar 22, 2011Philips Medical Systems North America Co. Phillips
Allura XPER FD 10 and Field Extension for XPER Cardiovascular System and Allura XPER FD 20 and Allura CV20. Angiographic X-ray systems with a solid state X-ray imaging device for cardiovascular and
Terminated
IZIK033737
K041949
Mar 16, 2011Philips Medical Systems North America Co. Phillips
Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO70800115.
Terminated
IZIK032046
Mar 16, 2011Philips Medical Systems North America Co. Phillips
Philips MultiDiagnost Eleva system, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO 70800114.
Terminated
IZIK023441
Mar 16, 2011Philips Medical Systems North America Co. Phillips
Philips Allura Integris Systems with OMCP Generator, x-ray diagnostic system. FCO72200185.
Terminated
IZIK984545
Mar 16, 2011Philips Medical Systems North America Co. Phillips
Philips Allura Xper Systems with Velara Generator, x-ray system. FCO72200184.
Terminated
IZIK022899
Jan 18, 2011Philips Medical Systems North America Co. Phillips
Philips OmniDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips OmniDiagnost Eleva is a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventiona
Terminated
IZIK032046
Jan 18, 2011Philips Medical Systems North America Co. Phillips
Philips MultiDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips MultiDiagnost Eleva is intended use as a multi-functional universal system, general RF, Fluoroscopy, Radiography and Angi
Terminated
IZIK023441
Jan 18, 2011Philips Medical Systems North America Co. Phillips
Philips EasyDiagnost Eleva with Digital Image (DI) Rel.2 system. The Philips EasyDiagnost Eleva intended use is for the following applications: As a diagnostic-imaging device multi-functional/univers
Terminated
IZIK031535
Dec 7, 2010Philips Medical Systems North America Co. Phillips
ALLURA XPER FD20/10 The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular
Terminated
IZINone listed
Dec 7, 2010Philips Medical Systems North America Co. Phillips
ALLURA XPER FD20 The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular dia
Terminated
IZINone listed
Dec 7, 2010Philips Medical Systems North America Co. Phillips
ALLURA XPER FD10/10 The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular
Terminated
IZINone listed
Dec 7, 2010Philips Medical Systems North America Co. Phillips
Allura XPER FD10 F/C The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular
Terminated
IZINone listed
Dec 7, 2010Philips Medical Systems North America Co. Phillips
Allura XPER X-ray system. The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vas
Terminated
IZINone listed
Dec 7, 2010Philips Medical Systems North America Co. Phillips
MultiDiagnost Eleva with FD. The Philips MultiDiagnost Eleva intended use is for the following applications: As a diagnostic-imaging device multi-functional/ universal system, general R/F, Fluoroscop
Terminated
IZINone listed
Oct 26, 2010Siemens Medical Solutions USA, Inc
AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755 Angiographic X-ray System
Terminated
IZIK021021
Oct 22, 2010Philips Medical Systems North America Co. Phillips
Allura Xper FD10/10 Biplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement
Terminated
IZIK041949
Oct 22, 2010Philips Medical Systems North America Co. Phillips
Allura Xper FD10 Monoplane X-ray system. Intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA and stent placement a
Terminated
IZIK041949

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.