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..
827
Total
827
Cleared
108d
Avg days
1976
Since
827 devices
Cleared
Jun 24, 1977
DELTASCAN 2000 SERIES
Ohio Nuclear, Inc.
Radiology
9d
Cleared
May 26, 1977
SYNERVIEW MODEL 6478
Philips Medical Systems (Cleveland), Inc.
Radiology
17d
Cleared
Mar 30, 1977
ACTA-SCANNER R 0200FS
Pfizer Medical Systems, Inc.
Radiology
5d
Cleared
Dec 30, 1976
SYNTEX SYSTEM 6000
Syntex Corp.
Radiology
3d
Cleared
Dec 30, 1976
HI-SENSITIVITY MODE OPTION FOR S60-1A
Syntex Corp.
Radiology
3d
Cleared
Nov 24, 1976
COMPUTERIZED TOMOGRAPHY SCANNER
Syntex Corp.
Radiology
9d
Cleared
Nov 19, 1976
GE CT/T MODEL NO. B7800 A
Arnold & Porter For G.E. Co.
Radiology
29d
Cleared
Nov 05, 1976
PHO. TRAX MODEL 4000 WHOLE BODY SCAN.
G.D. Searle and Co.
Radiology
24d
Cleared
Oct 05, 1976
X-RAY SCANNER, COMPUTERIZED TOMOGRAPHIC
American Science and Engineering, Inc.
Radiology
89d
Cleared
Oct 05, 1976
CT/N-II SCANNER SYSTEM
General Electric Co.
Radiology
15d