ClearanceBrief
Panels › Radiology › Product code JAA · Class 2

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)
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Top companies in JAA

DateFirm and productCodeLinked 510(k)
Jul 18, 2012GE 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
JAAK041932
Jun 22, 2012GE 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
JAAK993687
Apr 16, 2012Ziehm 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
JAAK061203
K073346 +2
Mar 23, 2012Philips Medical Systems Gmbh, DMC
Philips Easy Diagnost Eleva DRF, Software release 4.0 Fluoroscopic image-intensified Stationary X-Ray System.
Terminated
JAAK031535
Mar 16, 2012Philips 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
JAAK983069
Jan 27, 2012Siemens Medical Solutions USA, Inc
AXIOM Artis and AXIOM Artis zee modular angiographic systems Product Usage: Angiographic x-ray systems
Terminated
JAAK052202
Oct 27, 2011Philips Healthcare Inc.
Philips Verardius Image Intensified X-ray Catalog Number: 718130 Product Usage: Fluoroscopic x-ray system, image-intensified Fluoroscopic x-ray system.
Terminated
JAAK010435
Oct 27, 2011Philips 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
JAAK010435
Oct 27, 2011Philips 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
JAAK010435
Aug 12, 2011Hologic, 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
JAAK843920
Jul 8, 2011Philips 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
JAAK912470
May 6, 2011GE 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
JAANone listed
Apr 15, 2011Toshiba 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
JAANone listed
Apr 15, 2011Toshiba 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
JAANone listed
Apr 15, 2011Toshiba 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
JAANone listed
Apr 15, 2011Toshiba 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
JAANone listed
Oct 25, 2010Philips 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
JAAK010435
Oct 25, 2010Philips 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
JAAK010435
Sep 22, 2010Philips Medical Systems North America Co. Phillips
Philips BV Endura Mobile X-Ray system with the extended rotation option.
Terminated
JAAK010435
Sep 22, 2010Philips Medical Systems North America Co. Phillips
Philips BV Pulsera Mobile X-Ray system with the extended rotation option.
Terminated
JAAK010435
Mar 27, 2010Siemens Medical Solutions USA, Inc
Axiom Iconos R200 X-Ray
Terminated
JAAK992660
Jan 20, 2010Ge Healthcare
GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
Terminated
JAANone listed
Jan 20, 2010Ge Healthcare
GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
Terminated
JAANone listed
Nov 12, 2009Siemens 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
JAAK960266
Nov 9, 2009GE Medical Systems, LLC
Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System.
Terminated
JAAK060259
K061163
Sep 29, 2009NRT - 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
JAAK033486
Sep 24, 2009Philips Medical Systems North America Co. Phillips
Diagnost 76
Terminated
JAANone listed
Sep 24, 2009Philips Medical Systems North America Co. Phillips
Diagnost 96/97 DSI
Terminated
JAANone listed
Sep 24, 2009Philips Medical Systems North America Co. Phillips
OmniDiagnost
Terminated
JAAK982993
Sep 24, 2009Philips Medical Systems North America Co. Phillips
MultiDiagnost MD4
Terminated
JAAK961374
Sep 24, 2009Philips Medical Systems North America Co. Phillips
MultiDiagnost MD3
Terminated
JAANone listed
Sep 24, 2009Philips Medical Systems North America Co. Phillips
UroDiagnost
Terminated
JAANone listed
Sep 24, 2009Philips Medical Systems North America Co. Phillips
LithoDiagnost
Terminated
JAANone listed
Sep 24, 2009Philips Medical Systems North America Co. Phillips
Easy Diagnost Digital
Terminated
JAANone listed
Sep 24, 2009Philips Medical Systems North America Co. Phillips
EasyDiagnost
Terminated
JAANone listed
Sep 24, 2009Ge Healthcare
GE Healthcare Fluorostar 7900 Mobile Fluoroscopy System
Terminated
JAAK043076
Sep 24, 2009Philips Medical Systems North America Co. Phillips
EasyDiagnost Eleva x-ray systems
Terminated
JAAK031535
Sep 24, 2009Philips Medical Systems North America Co. Phillips
OminDiagnost Eleva
Terminated
JAAK032046
Sep 24, 2009Philips Medical Systems North America Co. Phillips
MultiDiagnost Eleva
Terminated
JAANone listed
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 10281151 Surgery lamp, 115V.
Terminated
JAAK052202
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 10281150 Surgery lamp, 230V.
Terminated
JAAK021021
May 6, 2009Siemens 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
JAAK951358
Jan 26, 2009Philips 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
JAAK062451
K071308
Jan 5, 2009OEC 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
JAAK073542
Jan 5, 2009OEC 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
JAAK073542
Sep 29, 2008OEC Medical Systems, Inc
GE Healthcare OEC 9900 mobile fluoroscopic x-ray system
Terminated
JAANone listed
Sep 26, 2008Medtronic 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
JAAK050996
Sep 25, 2008OEC 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
JAAK024012
Sep 25, 2008OEC 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
JAAK024012
Sep 20, 2008OEC Medical Systems, Inc
GE OEC 9600 C-arm Fluoroscopy System, GE Healthcare, Surgery, Salt Lake City, Utah.
Terminated
JAAK963952

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