System, X-Ray, Fluoroscopic, Image-Intensified
Regulation 892.1650
1510(k)s in 12 months (300 all time)
1recalls in 12 months (223 all time)
197recalls that name a 510(k)
Top companies in JAA
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 18, 2012 | GE OEC Medical Systems, Inc OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures.
The system is an aid to lo Terminated |
JAA | K041932 |
| Jun 22, 2012 | GE OEC Medical Systems, Inc OEC Uroview 2800, Model number A349855.
Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Terminated |
JAA | K993687 |
| Apr 16, 2012 | Ziehm Imaging Inc Double foot switch, type KF 2 1S/1 S-MED-AP, manufactured by the company Seute Schaltgerate. GmbH & Co. KG for Ziehm Imaging GmbH Germany, and used with Ziehm Imaging GmbH Mobile C-arm as a component Terminated |
JAA | K061203 K073346 +2 |
| Mar 23, 2012 | Philips Medical Systems Gmbh, DMC Philips Easy Diagnost Eleva DRF, Software release 4.0
Fluoroscopic image-intensified Stationary X-Ray System. Terminated |
JAA | K031535 |
| Mar 16, 2012 | Philips Healthcare Inc. DuoDiagnost, model 707015, Universal RF system
Product Usage: is a mult-functional diagnostic X-Ray system intended for Fluorosopic, Radiographic, Angiographic, and Interventional applications. Terminated |
JAA | K983069 |
| Jan 27, 2012 | Siemens Medical Solutions USA, Inc AXIOM Artis and AXIOM Artis zee modular angiographic systems
Product Usage: Angiographic x-ray systems Terminated |
JAA | K052202 |
| Oct 27, 2011 | Philips Healthcare Inc. Philips Verardius Image Intensified X-ray
Catalog Number: 718130
Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system. Terminated |
JAA | K010435 |
| Oct 27, 2011 | Philips Healthcare Inc. Philips BV Endura Fluoroscopic Image Intensified X-ray
Catalog Number: 718074
Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system. Terminated |
JAA | K010435 |
| Oct 27, 2011 | Philips Healthcare Inc. Philips BV Pulsera Fluoroscopic Image Intensified X-ray
Catalog Number: 718095
Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system. Terminated |
JAA | K010435 |
| Aug 12, 2011 | Hologic, Inc. Fluoroscan Mini C-arm, Models: FSIII, FSIIIC and Officemate
The Officemate, FSIII and FSIIIc are compact mobile fluoroscopic C-arm systems specifically designed for x-ray imaging of extremities. The Terminated |
JAA | K843920 |
| Jul 8, 2011 | Philips Healthcare Inc. Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System
The Diagnost is a multifunctional, universal X~ray system with remote controlled facilities. Routine examinations that can be per Terminated |
JAA | K912470 |
| May 6, 2011 | GE Healthcare, LLC Precision 500D X-ray systems with under-table collimator part number 5234960.
The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations. Terminated |
JAA | None listed |
| Apr 15, 2011 | Toshiba American Medical Systems Inc Toshiba Infinix-i, DFP-8000D
The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Terminated |
JAA | None listed |
| Apr 15, 2011 | Toshiba American Medical Systems Inc Toshiba Infinix-i, INFX-8000V
The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Terminated |
JAA | None listed |
| Apr 15, 2011 | Toshiba American Medical Systems Inc Toshiba Infinix-i, INFX-8000F
The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Terminated |
JAA | None listed |
| Apr 15, 2011 | Toshiba American Medical Systems Inc Toshiba Infinix-i, INFX-8000C
The expected usage of these devices is for fluoroscopy studies for various anatomical regions of the human body. Terminated |
JAA | None listed |
| Oct 25, 2010 | Philips Medical Systems North America Co. Phillips Philips BV Endura R2.2 Mobile X-ray system. The Type Product Code 718074 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device b Terminated |
JAA | K010435 |
| Oct 25, 2010 | Philips Medical Systems North America Co. Phillips Philips BV Pulsera R2.2 Mobile X-ray system. The Type Product Code 718094 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device Terminated |
JAA | K010435 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips BV Endura Mobile X-Ray system with the extended rotation option. Terminated |
JAA | K010435 |
| Sep 22, 2010 | Philips Medical Systems North America Co. Phillips Philips BV Pulsera Mobile X-Ray system with the extended rotation option. Terminated |
JAA | K010435 |
| Mar 27, 2010 | Siemens Medical Solutions USA, Inc Axiom Iconos R200 X-Ray Terminated |
JAA | K992660 |
| Jan 20, 2010 | Ge Healthcare GE OEC 9900 Elite GSP Fluoroscopes
To produce mobile fluoroscopic images of human anatomy. Terminated |
JAA | None listed |
| Jan 20, 2010 | Ge Healthcare GE OEC 9900 Elite ESP
To produce mobile fluoroscopic images of human anatomy. Terminated |
JAA | None listed |
| Nov 12, 2009 | Siemens Medical Solutions USA, Inc Siemens Medical Solutions USA, Inc., Siregraph CF X-Ray System, Model Number: 4466033.
Indended use: X-Ray, Fluoroscopic, Image-intensified. Terminated |
JAA | K960266 |
| Nov 9, 2009 | GE Medical Systems, LLC Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System. Terminated |
JAA | K060259 K061163 |
| Sep 29, 2009 | NRT - Nordisk Rontgen Teknik A/S Celex/GE Precision MPi, REF no.: 02980000
Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional Terminated |
JAA | K033486 |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Diagnost 76 Terminated |
JAA | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Diagnost 96/97 DSI Terminated |
JAA | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips OmniDiagnost Terminated |
JAA | K982993 |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips MultiDiagnost MD4 Terminated |
JAA | K961374 |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips MultiDiagnost MD3 Terminated |
JAA | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips UroDiagnost Terminated |
JAA | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips LithoDiagnost Terminated |
JAA | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips Easy Diagnost Digital Terminated |
JAA | None listed |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips EasyDiagnost Terminated |
JAA | None listed |
| Sep 24, 2009 | Ge Healthcare GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System Terminated |
JAA | K043076 |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips EasyDiagnost Eleva x-ray systems Terminated |
JAA | K031535 |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips OminDiagnost Eleva Terminated |
JAA | K032046 |
| Sep 24, 2009 | Philips Medical Systems North America Co. Phillips MultiDiagnost Eleva Terminated |
JAA | None listed |
| 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 10281151 Surgery lamp, 115V. Terminated |
JAA | K052202 |
| 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 10281150 Surgery lamp, 230V. Terminated |
JAA | K021021 |
| May 6, 2009 | Siemens Medical Solutions USA, Inc AXIOM Sireskop SX Model numbers 3111676 and 3111668. The product is intended for use as radiographic and fluoroscopic imaging device. Terminated |
JAA | K951358 |
| Jan 26, 2009 | Philips Medical Systems North America Co. Phillips NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software).
Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions acco Terminated |
JAA | K062451 K071308 |
| Jan 5, 2009 | OEC Medical Systems, Inc GE OEC 9900 Elite GSP fluoroscopic x-ray system GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy. Terminated |
JAA | K073542 |
| Jan 5, 2009 | OEC Medical Systems, Inc GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy. Terminated |
JAA | K073542 |
| Sep 29, 2008 | OEC Medical Systems, Inc GE Healthcare OEC 9900 mobile fluoroscopic x-ray system Terminated |
JAA | None listed |
| Sep 26, 2008 | Medtronic Navigation, Inc. BI-700-00027 0-arm 1000 Imaging System Mobile X-ray System
Generating 2D and 3D images of human anatomy for surgical applications. Terminated |
JAA | K050996 |
| Sep 25, 2008 | OEC Medical Systems, Inc GE OEC 9900 Elite Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy. Terminated |
JAA | K024012 |
| Sep 25, 2008 | OEC Medical Systems, Inc GE OEC 9800 Fluoroscopic X-Ray System, GE Healthcare, Surgery, Salt Lake City, Utah. The intended use of this device is to perform mobile fluoroscopic examination of human anatomy. Terminated |
JAA | K024012 |
| Sep 20, 2008 | OEC Medical Systems, Inc GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah. Terminated |
JAA | K963952 |
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