JAK · Class II · 21 CFR 892.1750

FDA Product Code JAK: System, X-ray, Tomography, Computed

FDA product code JAK covers computed tomography (CT) systems.

These diagnostic imaging systems use rotating X-ray beams and computer processing to generate detailed cross-sectional and three-dimensional images of the body. CT is widely used in emergency medicine, oncology, cardiology, and surgical planning.

JAK devices are Class II medical devices, regulated under 21 CFR 892.1750 and reviewed by the FDA Radiology panel.

Leading manufacturers include Siemens Medical Solutions USA, Inc., Toshiba America Medical Systems, In.C and General Electric Co..

822
Total
822
Cleared
108d
Avg days
1976
Since
822 devices
505–528 of 822
Cleared Sep 23, 1992
WRIST RESTRAINT FOR GE9800 C.T. TABLES
K923108
Cook, Inc.
Radiology · 90d
Cleared Sep 23, 1992
ADULT CHIN STRAP FOR CT TABLES
K923109
Cook, Inc.
Radiology · 90d
Cleared Sep 23, 1992
SCAN BAND
K923110
Cook, Inc.
Radiology · 90d
Cleared Sep 23, 1992
ARM EXTENDER FOR CT TABLES
K923111
Cook, Inc.
Radiology · 90d
Cleared Sep 23, 1992
HEAD RESTRAINT FOR CT TABLES
K923114
Cook, Inc.
Radiology · 90d
Cleared Sep 11, 1992
SCAN BAND
K923106
Cook, Inc.
Radiology · 78d
Cleared Jul 21, 1992
EXCEL CT TWIN
K915738
Elscint, Inc.
Radiology · 214d
Cleared May 28, 1992
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TF
K921432
Shimadzu Medical Systems
Radiology · 64d
Cleared Feb 27, 1992
SYTEC DENTASCAN
K914305
General Electric Co.
Radiology · 155d
Cleared Feb 14, 1992
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TE
K915623
Shimadzu Medical Systems
Radiology · 60d
Cleared Jan 23, 1992
CT SYTEC 8000
K913485
General Electric Co.
Radiology · 170d
Cleared Nov 22, 1991
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K913996
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared Oct 15, 1991
GYROVIEW-HR
K913029
Philips Medical Systems, Inc.
Radiology · 98d
Cleared Sep 27, 1991
KODAK EKTASCAN XLP PRELIMINARY DV2000 INTERFACE
K912454
Eastman Kodak Company
Radiology · 116d
Cleared Sep 06, 1991
PHILIPS TOMOSCAN SR
K912752
Philips Medical Systems North America, Inc.
Radiology · 77d
Cleared Aug 26, 1991
LITEBOX
K913252
Siemens Gammasonics, Inc.
Radiology · 35d
Cleared Jul 17, 1991
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TH
K911500
Shimadzu Medical Systems
Radiology · 105d
Cleared Jul 17, 1991
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-5000TX
K911501
Shimadzu Medical Systems
Radiology · 105d
Cleared May 17, 1991
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM
K910859
Siemens Medical Solutions USA, Inc.
Radiology · 78d
Cleared May 09, 1991
CT SYTEC 4000
K911387
GE Medical Systems
Radiology · 41d
Cleared Mar 15, 1991
HELICAL SCAN
K910375
Toshiba America Medical Systems, In.C
Radiology · 45d
Cleared Jan 14, 1991
CT HILIGHT ADVANTAGE II
K904971
GE Medical Systems
Radiology · 70d
Cleared Nov 07, 1990
XPRESS
K903701
Toshiba America Medical Systems, In.C
Radiology · 84d
Cleared Nov 02, 1990
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K903763
General Electric Co.
Radiology · 74d