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 Shimadzu Medical Systems.

300
Total
300
Cleared
89d
Avg days
1976
Since
300 devices
73–96 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 Aug 23, 2001
ISI-2500 CCD C-ARM, ISI-2500 PLUS CCD C-ARM
K010772
Imaging Services, Inc.
Radiology · 162d
Cleared Jun 08, 2001
EXPEDIO 500D R&F X-RAY SYSTEM
K011624
GE Medical Systems
Radiology · 14d
Cleared Mar 12, 2001
ATHENA REMOTE CONTROLLED RF SYSTEM
K010392
Cares Built, Inc.
Radiology · 32d
Cleared Feb 14, 2001
KIMAX, MODEL 1024
K010187
Medical Metrics, Inc.
Radiology · 23d
Cleared Feb 02, 2001
X-RAY SYSTEM XR-MX
K004037
Karl Storz Endoscopy
Radiology · 36d
Cleared Jun 01, 2000
VFSS IMAGER, MODEL SIS-300
K000987
Lifecare Imaging Intl., Ltd.
Radiology · 66d
Cleared Mar 27, 2000
MCA-601, C-ARM MOBILE
K993896
Medison Radiology Systems, Inc.
Radiology · 132d
Cleared Oct 25, 1999
XRT 600 R/F, WRF 0600
K992603
Wuestec Medical, Inc.
Radiology · 83d
Cleared Oct 07, 1999
TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)
K993038
Toshiba America Medical Systems, In.C
Radiology · 27d
Cleared Feb 02, 1999
B-400 CEILING MOUNTED POSSITIONER, MODEL B-400
K990055
Omega Medical Imaging, Inc.
Radiology · 26d
Cleared Sep 22, 1998
CAREGRAPH
K982319
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Sep 01, 1998
VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM
K982345
Cardiac Mariners, Inc.
Radiology · 57d
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 Jun 30, 1998
SYMPHONY 360 REMOTE CONTROL TABLE
K981227
Acoma Medical Imaging, Inc.
Radiology · 88d
Cleared Jan 12, 1998
FS IV MINI C-ARM SYSTEM
K974058
Hologic, Inc.
Radiology · 77d
Cleared Dec 29, 1997
UNICATH SP BI-PLANE (MODEL M269 & M289)
K973744
Xre Corp.
Radiology · 89d
Cleared Oct 16, 1997
DRTS REMOTE CONTROL DRAPE
K973067
Minrad, Inc.
Radiology · 59d
Cleared Oct 08, 1997
DRTS IMAGE INTENSIFIER DRAPE
K973073
Minrad, Inc.
Radiology · 51d
Cleared Sep 11, 1997
CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002
K972442
Continental X-Ray Corp.
Radiology · 73d
Cleared May 14, 1997
B-350 CEILING MOUNTED C-POSITIONER
K970947
Omega Medical Imaging, Inc.
Radiology · 61d