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, General Electric Co. and Siemens Medical Solutions USA, Inc..

300
Total
300
Cleared
89d
Avg days
1976
Since
300 devices
49–72 of 300
Cleared Jun 06, 2002
MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
K021021
Siemens Medical Solutions USA, Inc.
Radiology · 69d
Cleared Mar 15, 2002
PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION
K020055
Philips Medical Systems
Radiology · 66d
Cleared Oct 18, 2001
SHIMADZU IMAGE AMPLIFIER MODEL # IA-16LM
K012424
Shimadzu Corp.
Radiology · 80d
Cleared Jun 08, 2001
EXPEDIO 500D R&F X-RAY SYSTEM
K011624
GE Medical Systems
Radiology · 14d
Cleared Feb 02, 2001
X-RAY SYSTEM XR-MX
K004037
Karl Storz Endoscopy
Radiology · 36d
Cleared Oct 07, 1999
TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)
K993038
Toshiba America Medical Systems, In.C
Radiology · 27d
Cleared Sep 22, 1998
CAREGRAPH
K982319
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Jul 16, 1998
LC POSITIONER
K981414
Fischer Imaging Corp.
Radiology · 87d
Cleared Jul 14, 1998
FLUOROSPOT COMPACT
K982028
Siemens Medical Solutions USA, Inc.
Radiology · 35d
Cleared Jan 12, 1998
FS IV MINI C-ARM SYSTEM
K974058
Hologic, Inc.
Radiology · 77d
Cleared Feb 26, 1997
HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)
K964990
Hitachi Medical Systems America, Inc.
Radiology · 72d
Cleared Dec 18, 1996
C-ARM TABLE IVS-100
K963888
Shimadzu Medical Systems
Radiology · 83d
Cleared Nov 08, 1996
SHIMADZU X-RAY DIAGNOSTIC TABLE YSF-120
K963617
Shimadzu Medical Systems
Radiology · 59d
Cleared Aug 20, 1996
EP-X BIPLANE
K961207
Fischer Imaging Corp.
Radiology · 146d
Cleared Mar 11, 1996
SIREGRAPH CF
K960266
Siemens Medical Solutions USA, Inc.
Radiology · 53d
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 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