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
145–168 of 300
Cleared Jan 09, 1989
UNIVERSAL ABC CONTROLER
K883580
Philips Medical Systems (Cleveland), Inc.
Radiology · 140d
Cleared Dec 20, 1988
MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM
K884317
Medrad, Inc.
Radiology · 68d
Cleared Nov 25, 1988
ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
K883372
Ausonics Pty , Ltd.
Radiology · 107d
Cleared Nov 21, 1988
CARDIAC CX
K883985
Fischer Imaging Corp.
Radiology · 62d
Cleared Sep 14, 1988
SHIMADZU LATERAL C-ARM MH-31
K882311
Shimadzu Precision Instruments, Inc.
Radiology · 103d
Cleared Feb 29, 1988
CEILING MOUNTED FLUOROSCOPIC C-ARM ARIEL C-ARM
K880527
Fischer Imaging Corp.
Radiology · 20d
Cleared Jan 29, 1988
REVELATION, RADIO FLUOROSCOPIC X-RAY EXAM TABLE
K874901
Fischer Imaging Corp.
Radiology · 59d
Cleared Jan 19, 1988
SHIMADZU CATHETERIZATION C-ARM STAND MH-50A
K875157
Shimadzu Precision Instruments, Inc.
Radiology · 35d
Cleared Jun 22, 1987
LP LATERAL FLUORO POSITIONER (B5077A)
K872061
General Electric Co.
Radiology · 25d
Cleared May 01, 1987
DTV-411OP
K870869
Adac Laboratories
Radiology · 59d
Cleared May 01, 1987
DTV-4112 FLUOROSCOPIC TELEVISION CAMERA
K871127
Adac Laboratories
Radiology · 42d
Cleared Mar 31, 1987
CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D
K871119
Canon USA, Inc.
Radiology · 12d
Cleared Jun 16, 1986
SCX SYSTEM
K862120
General Electric Co.
Radiology · 13d
Cleared Jan 10, 1986
PET-SCOPE II IMAGE INTENSIFIER
K855213
Philips Medical Systems (Cleveland), Inc.
Radiology · 11d
Cleared Oct 16, 1985
CANON X-RAY IMAGE DISTRIBUTOR
K853984
Canon USA, Inc.
Radiology · 19d
Cleared Apr 09, 1985
EQUIPMENT SNAP KOVERS
K850959
Advance Medical Designs, Inc.
Radiology · 32d
Cleared Nov 08, 1984
STENOSCOP
K843235
Cgr Medical Corp.
Radiology · 84d
Cleared Mar 19, 1984
REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY
K840364
Advanced Technology Laboratories, Inc.
Radiology · 53d
Cleared Mar 16, 1984
DIGITAL FLUOROGRAPHY X-RAY SYSTEM
K840191
Adac Laboratories
Radiology · 58d
Cleared Feb 21, 1984
TECHNICARE MODEL 1047
K840390
Technicare Corp.
Radiology · 22d
Cleared Jan 10, 1984
DIGITAL RADIOGRAPHY SYS-DPS7100
K834287
Adac Laboratories
Radiology · 46d
Cleared Jan 04, 1984
BI-PLANE DIGITAL FLUOROGRAPHY DFX7000
K834286
Adac Laboratories
Radiology · 40d
Cleared Dec 30, 1983
IMAGE INTENSIFIER TUBE W/HOUSING &
K833641
Varian Assoc., Inc.
Radiology · 74d
Cleared Nov 21, 1983
REGISTREX 1000 DIGITAL RADIOGRAPHY SYS
K833230
Advanced Technology Laboratories, Inc.
Radiology · 89d