JAA · Class II · 21 CFR 892.1650

FDA Product Code JAA: System, X-ray, Fluoroscopic, Image-intensified

Leading manufacturers include Toshiba America Medical Systems, In.C, Siemens Medical Solutions USA, Inc. and Fischer Imaging Corp..

300
Total
300
Cleared
89d
Avg days
1976
Since
300 devices
73–96 of 300
Cleared May 09, 1994
EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER
K926560
Fischer Imaging Corp.
Radiology · 494d
Cleared Feb 07, 1994
SHIMADZU DIGITAL SUBSTRACTION SYST DAR-2400 SERIES
K933472
Shimadzu Corp.
Radiology · 207d
Cleared Nov 24, 1993
CATHETERIZATION C-ARM SUPPORT MH-51BM/MH-51CM
K933473
Shimadzu Corp.
Radiology · 132d
Cleared Nov 22, 1993
PHILIPS ANGIOPRO RELEASE 2.1
K933791
Philips Medical Systems North America, Inc.
Radiology · 110d
Cleared Nov 03, 1993
EP-X
K934481
Fischer Imaging Corp.
Radiology · 50d
Cleared Sep 07, 1993
SIRESKOP CX
K932445
Siemens Medical Solutions USA, Inc.
Radiology · 110d
Cleared Feb 12, 1993
FLUOREX
K926122
Toshiba America Medical Systems, In.C
Radiology · 70d
Cleared Nov 27, 1992
BODY BAND RESTRAINT STRAP SET
K923107
Cook, Inc.
Radiology · 155d
Cleared Oct 09, 1992
MEDRAD PATHFINDER-E ROADMAPPING SYSTEM
K922274
Medrad, Inc.
Radiology · 148d
Cleared Oct 05, 1992
SHIMADZU IMAGE AMPLIFIER IA-9LM SERIES
K923453
Shimadzu Medical Systems
Radiology · 83d
Cleared Oct 05, 1992
SHIMADZU IMAGE AMPLIFIER IA-9LS SERIES
K923454
Shimadzu Medical Systems
Radiology · 83d
Cleared Aug 07, 1992
ELECTRONIC PHOTOSPOT 20
K922240
Toshiba America Medical Systems, In.C
Radiology · 86d
Cleared Jun 16, 1992
SHIMADZU IMAGE AMPLIFIER IA-12VSA SERIES
K922012
Shimadzu Medical Systems
Radiology · 48d
Cleared Jun 10, 1992
SHIMADZU IMAGE AMPLIFIER IA-12VDA SERIES
K922011
Shimadzu Medical Systems
Radiology · 42d
Cleared Jun 10, 1992
SHIMADZU IMAGE AMPLIFIER IA-12VMA SERIES
K922013
Shimadzu Medical Systems
Radiology · 42d
Cleared Apr 20, 1992
DIGITAL RADIOGRAPHY SYSTEM IDR-1000
K920720
Shimadzu Medical Systems
Radiology · 62d
Cleared Apr 15, 1992
DIGITAL RADIOGRAPHY SYSTEM IDR-2000
K920721
Shimadzu Medical Systems
Radiology · 57d
Cleared Jan 13, 1992
PEGASUS LATERAL CARDIAC POSITIONER
K915592
Fischer Imaging Corp.
Radiology · 31d
Cleared Nov 27, 1991
FVP-1000 FAMILY AND FVP-1000D FAMILY
K905694
Fischer Imaging Corp.
Radiology · 343d
Cleared Nov 19, 1991
FLUROSPOT H VERSION 2
K914525
Siemens Medical Solutions USA, Inc.
Radiology · 40d
Cleared Aug 07, 1991
PHILIPS DIAGNOST 96
K912470
Philips Medical Systems, Inc.
Radiology · 64d
Cleared Jul 19, 1991
LASER BEAM LOCALIZER FOR SIREMOBIL 4
K912380
Siemens Medical Solutions USA, Inc.
Radiology · 51d
Cleared Nov 29, 1990
PHILIPS INTEGRIS I 2000 SYSTEM
K904012
Philips Medical Systems, Inc.
Radiology · 92d
Cleared May 07, 1990
DIGIFORMER HR DFP-50A
K901405
Toshiba America Medical Systems, In.C
Radiology · 42d