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, Fischer Imaging Corp. and Siemens Medical Solutions USA, Inc..

300
Total
300
Cleared
89d
Avg days
1976
Since
300 devices
97–120 of 300
Cleared Jul 25, 1996
ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM MODEL NO. 6896.300
K962140
Continental X-Ray Corp.
Radiology · 52d
Cleared Jun 27, 1996
CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105
K961690
Continental X-Ray Corp.
Radiology · 57d
Cleared Jun 17, 1996
FULL FRAME ZOOM SYSTEM
K961193
Xre Corp.
Radiology · 88d
Cleared Jun 03, 1996
RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY
K955687
Contour Fabricators of Florida, Inc.
Radiology · 172d
Cleared Mar 29, 1996
SBDX MOBILE FLUOROSCOPY SYSTEM
K953113
Cardiac Mariners, Inc.
Radiology · 270d
Cleared Mar 15, 1996
DFI-1000 AND DVS-475 IMAGING DEVICES
K951261
Nical
Radiology · 360d
Cleared Mar 11, 1996
SIREGRAPH CF
K960266
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared Jan 29, 1996
HANEL MAVIG MONITOR SUSPENSION SYSTEM
K954945
F. Walter Hanel GmbH
Radiology · 91d
Cleared Nov 20, 1995
MAX-1000A/R1
K954590
Toshiba America Medical Systems, In.C
Radiology · 49d
Cleared May 24, 1995
FLUOREX DTA-400A
K946081
Toshiba America Medical Systems, In.C
Radiology · 162d
Cleared May 15, 1995
SIRESKOP SX
K951358
Siemens Medical Solutions USA, Inc.
Radiology · 52d
Cleared May 11, 1995
SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES
K936236
Shimadzu Medical Systems
Radiology · 497d
Cleared May 06, 1995
ARTHROGRAM TRAY
K950683
Surgical Technologies, Inc.
Radiology · 81d
Cleared Mar 14, 1995
PHILIPS CD MEDICAL RECORDER, VIEW STATION, DUP[[LICATION STATION
K945460
Philips Medical Systems North America, Inc.
Radiology · 127d
Cleared Dec 14, 1994
NRF SYSTEM
K944973
Philips Medical Systems (Cleveland), Inc.
Radiology · 64d
Cleared Nov 28, 1994
V-MAX OPTIONS
K943447
Philips Medical Systems (Cleveland), Inc.
Radiology · 133d
Cleared Sep 23, 1994
PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD
K943805
General Electric Co.
Radiology · 50d
Cleared May 13, 1994
TDA-4000/A4
K941611
Toshiba America Medical Systems, In.C
Radiology · 39d
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