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 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
Cleared Apr 21, 1997
EVT MARKER BOARD
K970608
Guidant Cardiac and Vascular Surgery
Radiology · 62d
Cleared Mar 28, 1997
BIO-BINKI
K961782
Biomni Medical Systems, Inc.
Radiology · 324d
Cleared Feb 26, 1997
VIPOR UNIT
K964322
Tilane Corp.
Radiology · 120d
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 Sep 20, 1996
FLUOROPLUS CARDIAC TV
K961140
Cmt Medical Technologies, Ltd.
Radiology · 183d
Cleared Sep 09, 1996
CAMVISION 1000
K953974
Medivision Medical Imaging, Ltd.
Radiology · 383d
Cleared Aug 20, 1996
EP-X BIPLANE
K961207
Fischer Imaging Corp.
Radiology · 146d
Cleared Aug 07, 1996
TOPOGRAPHIC IMAGING MARKER
K962606
I.Z.I. Medical Products Corp.
Radiology · 36d