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
97–120 of 300
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
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 Sep 18, 1995
FLUORO CATHETER
K953950
Cmt Medical Technologies, Ltd.
Radiology · 27d
Cleared Jun 22, 1995
FLUORECORD MODEL 762
K952493
Syracuse Scientific, Inc.
Radiology · 23d
Cleared Jun 16, 1995
IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
K952456
Fisher Imaging Corp.
Radiology · 22d
Cleared Jun 05, 1995
COMPACT 7600
K950781
Ge Dec Medical Systems
Radiology · 104d
Cleared May 24, 1995
FLUOREX DTA-400A
K946081
Toshiba America Medical Systems, In.C
Radiology · 162d