IZF · Class II · 21 CFR 892.1740

FDA Product Code IZF: System, X-ray, Tomographic

Leading manufacturers include Nano-X Imaging , Ltd., Siemens Corp. and Continental X-Ray Corp..

42
Total
42
Cleared
85d
Avg days
1976
Since
42 devices
25–42 of 42
Cleared Mar 16, 1989
RESUBMITTED SCANORA
K884650
Orion Corp.
Radiology · 129d
Cleared Sep 19, 1985
ORALIX PANORAMIC D.C.
K852768
Philips Medical Systems, Inc.
Radiology · 83d
Cleared Dec 29, 1983
DIGITILT LS-30 REMOTE CONTROL
K834288
Elscint, Inc.
Radiology · 31d
Cleared Jun 23, 1981
SOMATOM 2N
K811302
Siemens Corp.
Radiology · 43d
Cleared Jun 09, 1981
SUPERIX 120
K811197
Tecnomed, Inc.
Radiology · 40d
Cleared Mar 11, 1981
CLINIX-R TOMOGRAPHIC DEVICE
K810274
Philips Medical Systems (Cleveland), Inc.
Radiology · 37d
Cleared Mar 11, 1981
ZONOGRAPH 6
K810307
Siemens Corp.
Radiology · 34d
Cleared Dec 20, 1979
INTEGRON
K792327
Tecnomed, Inc.
Radiology · 31d
Cleared Dec 10, 1979
VTX (GE CATAOLG NO. B7005A)
K792067
General Electric Co.
Radiology · 56d
Cleared Apr 26, 1979
MULTIGRAPH
K790765
Siemens Corp.
Radiology · 7d
Cleared Feb 21, 1979
TECNOTOMO
K790132
Teknomed, Inc.
Radiology · 29d
Cleared Sep 14, 1978
OPTIPLANIMAT
K781531
Siemens Corp.
Radiology · 8d
Cleared Jun 22, 1978
COMPUTERIZED AXIAL TOMOGRAPHY
K780995
Emi Medical, Inc.
Radiology · 8d
Cleared Mar 14, 1978
ORBITOME-UG
K780319
Philips Medical Systems (Cleveland), Inc.
Radiology · 18d
Cleared Aug 25, 1977
VERSATOME
K771549
Kermath Mfg. Corp.
Radiology · 13d
Cleared Aug 03, 1977
TUBE CONVEYOR MODEL DS-PB-4
K771296
Toshiba Medical Systems
Radiology · 55d
Cleared Aug 03, 1977
TUBESTAND MODEL DS-TA-4
K771297
Toshiba Medical Systems
Radiology · 55d
Cleared Dec 16, 1976
X-RAY SCANNER, WHOLE BODY, AS&E
K761004
American Science and Engineering, Inc.
Radiology · 38d