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..

827
Total
827
Cleared
108d
Avg days
1976
Since
827 devices
745–768 of 827
Cleared Aug 19, 1988
DENTASCAN
K882906
Mpdi, Inc.
Radiology · 38d
Cleared Aug 15, 1988
TOMOSCAN LX COMPUTED TOMOGRAPHY SYSTEM
K882022
Philips Medical Systems, Inc.
Radiology · 94d
Cleared Aug 15, 1988
CT MAX 640 #B7940 JA/JE
K882581
General Electric Co.
Radiology · 54d
Cleared Jul 26, 1988
XENON CT
K875088
Siemens Medical Solutions USA, Inc.
Radiology · 230d
Cleared May 18, 1988
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-3000TX
K875370
Shimadzu Precision Instruments, Inc.
Radiology · 139d
Cleared Mar 28, 1988
PICS-2000
K880822
Philips Medical Systems, Inc.
Radiology · 27d
Cleared Mar 28, 1988
SOMATOM PLUS
K880965
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Feb 25, 1988
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-2000T-11
K874767
Shimadzu Precision Instruments, Inc.
Radiology · 98d
Cleared Sep 23, 1987
CT PACE CATALOG NUMBER B7950A
K872526
General Electric Co.
Radiology · 90d
Cleared Sep 23, 1987
IMATRON C-100 ULTRAFAST CT SCANNER
K872615
Imatron, Inc.
Radiology · 79d
Cleared Aug 12, 1987
CT9800 QUICK 3D #B7919DA
K871859
General Electric Co.
Radiology · 91d
Cleared Aug 12, 1987
I.S.G. 3DMV WORKSTATION
K872150
I.S.G. Technologies, Inc.
Radiology · 69d
Cleared May 08, 1987
CSI/3D
K870513
Columbia Scientific, Inc.
Radiology · 92d
Cleared Dec 02, 1986
TOSHIBA TCT-600 COMPUTED TOMOGRAPHY (CT) X-RAY
K863935
Toshiba Medical Systems
Radiology · 54d
Cleared Nov 10, 1986
C-IOO MOBILE CINE CT UNIT
K864046
Imatron, Inc.
Radiology · 25d
Cleared Oct 07, 1986
CT MAX, CATALOG NO. B7940 HA
K862317
General Electric Co.
Radiology · 111d
Cleared Oct 03, 1986
VISISCAN CT SCANNERS - MODELS V600, V1200 & V2400
K861698
Visiscan
Radiology · 151d
Cleared Aug 29, 1986
SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC
K861708
General Electric Co.
Radiology · 116d
Cleared Nov 15, 1985
TECHNICARE 720 HPS CT SCANNER
K854340
Technicare Corp.
Radiology · 18d
Cleared Nov 08, 1985
TOSHIBA TCT-900S COMPUTED TOMOGRAPHY CT X-RAY SYS
K853444
Toshiba Medical Systems
Radiology · 84d
Cleared Oct 10, 1985
OPTICAL DISC UNIT
K852865
General Electric Co.
Radiology · 94d
Cleared Apr 16, 1985
HEAD-SPINE STABILIZER HSS-1
K844926
Imaging Accessories, Inc.
Radiology · 118d
Cleared Apr 04, 1985
MEDITECH EUROSCANNER M250
K850027
Stuart Medical, Inc.
Radiology · 90d
Cleared Dec 17, 1984
CT 9000
K843927
General Electric Co.
Radiology · 73d