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) |
|---|---|---|---|
| Dec 16, 2014 | GE 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 |
IZI | K122457 |
| Dec 1, 2014 | Novadaq Technologies, Inc. Non-sterile drape Terminated |
IZI | K071619 |
| Dec 1, 2014 | Novadaq Technologies, Inc. LUNA Chest, Model No. LU4006 Terminated |
IZI | K071619 |
| Dec 1, 2014 | Siemens 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 |
IZI | K073290 |
| Nov 7, 2014 | Siemens 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 |
IZI | K073290 |
| Sep 24, 2014 | Philips 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 |
IZI | K031333 K033737 +3 |
| Sep 24, 2014 | Siemens 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 |
IZI | K010721 K073290 |
| Sep 22, 2014 | Siemens Medical Solutions USA, Inc Artis zee and Artis zeego systems.
x-ray, angiographic system Terminated |
IZI | K073290 |
| May 8, 2014 | Shimadzu 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 |
IZI | K052500 |
| Mar 31, 2014 | Siemens Medical Solutions USA, Inc Artis Zee Angiographic x-ray systems. Terminated |
IZI | K073290 |
| Mar 22, 2014 | Siemens 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 |
IZI | K073290 |
| Feb 24, 2014 | Siemens Medical Solutions USA, Inc Siemens Artis zee Ceiling Systems.
Angiographic x-ray system. Terminated |
IZI | K073290 |
| Jan 28, 2014 | GE 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 |
IZI | K122457 |
| Nov 14, 2013 | Siemens Medical Solutions USA, Inc Artis zee systems
x-ray, angiographic system Terminated |
IZI | K090745 |
| Aug 28, 2013 | Siemens Medical Solutions USA, Inc Axiom Artis systems. C-arm angiographic x-ray system
x-ray, angiographic system. Terminated |
IZI | K021021 |
| Aug 9, 2013 | Siemens Medical Solutions USA, Inc Siemens AXIOM Artis zeego
x-ray, angiographic system Terminated |
IZI | K090745 |
| Jul 22, 2013 | Siemens 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 |
IZI | K073290 K090745 |
| Jul 17, 2013 | Siemens Medical Solutions USA, Inc Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus
Product Usage:
Angiographic x-ray system Terminated |
IZI | K090745 |
| Mar 26, 2013 | Siemens Medical Solutions USA, Inc Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed.
Angiographic x-ray system Terminated |
IZI | K073290 K090745 |
| Mar 25, 2013 | Siemens 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 |
IZI | K090745 |
| Oct 17, 2012 | GE 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 |
IZI | None listed |
| Oct 17, 2012 | GE 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 |
IZI | None listed |
| Oct 17, 2012 | GE 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 |
IZI | None listed |
| Jun 20, 2012 | Philips 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 |
IZI | K023441 K050151 |
| Apr 25, 2012 | Philips Healthcare Inc. Allura X-ray System.
The Allura X-ray System is an angiographic X-ray system. Terminated |
IZI | K031333 K033737 |
| Mar 29, 2012 | Philips Healthcare Inc. Philips Healthcare MD Eleva system.
Multi-functional fluoroscopy, radiography and angiography systems that can perform more specialized interventional applications Terminated |
IZI | None listed |
| Mar 19, 2012 | GE 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 |
IZI | None listed |
| Mar 9, 2012 | Philips 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 |
IZI | K023441 |
| Mar 9, 2012 | Philips 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 |
IZI | K023441 |
| Feb 8, 2012 | Philips 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 |
IZI | K023441 |
| Feb 2, 2012 | Philips 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 |
IZI | K050151 |
| Aug 10, 2011 | Philips 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 |
IZI | K031333 K033737 +1 |
| Mar 22, 2011 | Philips 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 |
IZI | None listed |
| Mar 22, 2011 | Philips 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 |
IZI | K033737 K041949 |
| Mar 16, 2011 | Philips Medical Systems North America Co. Phillips Philips OmniDiagnost Eleva, a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications. FCO70800115. Terminated |
IZI | K032046 |
| Mar 16, 2011 | Philips 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 |
IZI | K023441 |
| Mar 16, 2011 | Philips Medical Systems North America Co. Phillips Philips Allura Integris Systems with OMCP Generator, x-ray diagnostic system. FCO72200185. Terminated |
IZI | K984545 |
| Mar 16, 2011 | Philips Medical Systems North America Co. Phillips Philips Allura Xper Systems with Velara Generator, x-ray system. FCO72200184. Terminated |
IZI | K022899 |
| Jan 18, 2011 | Philips 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 |
IZI | K032046 |
| Jan 18, 2011 | Philips 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 |
IZI | K023441 |
| Jan 18, 2011 | Philips 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 |
IZI | K031535 |
| Dec 7, 2010 | Philips 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 |
IZI | None listed |
| Dec 7, 2010 | Philips 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 |
IZI | None listed |
| Dec 7, 2010 | Philips 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 |
IZI | None listed |
| Dec 7, 2010 | Philips 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 |
IZI | None listed |
| Dec 7, 2010 | Philips 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 |
IZI | None listed |
| Dec 7, 2010 | Philips 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 |
IZI | None listed |
| Oct 26, 2010 | Siemens 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 |
IZI | K021021 |
| Oct 22, 2010 | Philips 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 |
IZI | K041949 |
| Oct 22, 2010 | Philips 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 |
IZI | K041949 |
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