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

Company	510(k)s	Recalls
Ge Oec Medical Systems	1	40
Siemens Medical Solutions USA, Inc.	10	29
GE Healthcare	1	33
Philips North America	0	23
Philips Medical Systems North America Co. Phillips	0	22
Shimadzu Medical Systems	10	5
Fischer Imaging Corp.	10	4
Philips Medical Systems Dmc GmbH	5	9
Toshiba America Medical Systems, In.C	13	0
General Electric Co.	10	0

Date	Firm and product	Code	Linked 510(k)
May 6, 2006	Philips Medical Systems North America Co. Phillips MD4 X-ray system Terminated	JAA	K961374
May 6, 2006	Philips Medical Systems North America Co. Phillips MD3 X-ray system Terminated	JAA	K904012
Feb 23, 2006	Toshiba American Med Sys Inc Toshiba Digital Radiography System Model DFP8000D Terminated	JAA	K013608
Feb 14, 2006	General Electric Med Systems LLC Precision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision 500D system consists of an X-ray generator; angulating table with X-ray Tube, collimator and image Terminated	JAA	K011624
Dec 23, 2005	Toshiba American Med Sys Inc Digital Radiography System Model DFP-8000D/FPD, Terminated	JAA	None listed
Dec 23, 2005	Toshiba American Med Sys Inc Digital Radiography System Model DFP8000D Terminated	JAA	None listed
Nov 24, 2005	Toshiba American Med Sys Inc High voltage generator XTP-8100G and XTPG-8100G for the Infinix-i series interventional angiography system. Terminated	JAA	None listed
Sep 9, 2005	Fischer Imaging Corporation Electrophysiology Imaging System Terminated	JAA	None listed
Sep 9, 2005	Fischer Imaging Corporation Electrophysiology Imaging System Terminated	JAA	K912448 K934481 +1
Sep 9, 2005	Fischer Imaging Corporation Electrophysiology Imaging System Terminated	JAA	K912448 K934481 +1
Sep 9, 2005	Fischer Imaging Corporation Electrophysiology Imaging System Terminated	JAA	K912448 K934481 +1
Apr 8, 2005	OEC Medical Systems, Inc FluroTrak 9800 Plus Navigation and Visualization System Terminated	JAA	K022069
Sep 18, 2004	Siemens Medical Solutions USA, Inc Siregraph CF X-Ray System. Fluoroscopic image intensified. Model number 4466041 Terminated	JAA	K960266
Sep 18, 2004	Siemens Medical Solutions USA, Inc Siregraph CF X-Ray System. Fluoroscopic image intensified. Model number 4466033 Terminated	JAA	K960266
Aug 11, 2004	Toshiba American Med Sys Inc Digital Radiography System, model DFP-8000D Terminated	JAA	K013608
Jul 20, 2004	Advance Medical Designs Inc Advance Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufactured by Advance Medical Designs, Inc., 1241 Atlanta Industrial Drive, Marietta, Terminated	JAA	K850959
Jul 20, 2004	Medstone International Inc URO PRO Plus Digital Urology Imaging System Terminated	JAA	None listed
Nov 6, 2003	Toshiba American Med Sys Inc Digital Fluorographic System model DFP-2000A. Terminated	JAA	K941611
Oct 15, 2003	Siemens Medical Solutions USA, Inc Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive Terminated	JAA	K923049
Jun 21, 2003	GE OEC Medical Systems,Inc Uroview 2600 Uroview System Terminated	JAA	K940295
Jun 21, 2003	GE OEC Medical Systems,Inc Uroview 2500 X-ray System Terminated	JAA	K914446
Jun 21, 2003	GE OEC Medical Systems,Inc Uroview 2000 X-ray System Terminated	JAA	K893475 K914446
Feb 27, 2003	Philips Medical Systems MultiDiagnost 4 - x-ray system, multi functional/universal system for general use. Terminated	JAA	K961374

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