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
625–648 of 827
Cleared Sep 30, 1998
SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS
K982349
Siemens Medical Solutions USA, Inc.
Radiology · 86d
Cleared Sep 02, 1998
VOLUMAX CT IMAGING SYSTEM
K982060
Elscint, Inc.
Radiology · 83d
Cleared Aug 26, 1998
AQUILION CT SCANNER, MODEL TSX-101A
K982265
Toshiba America Medical Systems, In.C
Radiology · 58d
Cleared Aug 18, 1998
CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS
K982004
General Electric Co.
Radiology · 71d
Cleared Jul 06, 1998
ADVANTAGE 3D XR
K974715
GE Medical Systems
Radiology · 201d
Cleared Jun 03, 1998
CT SCOPE
K974344
Elscint, Inc.
Radiology · 196d
Cleared May 20, 1998
PINPOINT
K974513
Philips Medical Systems (Cleveland), Inc.
Radiology · 170d
Cleared May 20, 1998
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS
K980837
Shimadzu Medical Systems
Radiology · 77d
Cleared Apr 13, 1998
HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS
K980169
General Electric Co.
Radiology · 87d
Cleared Apr 13, 1998
HISPEED QX/I CT SCANNER SYSTEM
K980176
General Electric Co.
Radiology · 83d
Cleared Feb 20, 1998
ANATOM 1000 (A MINUS, A-)
K974455
Analogic Corp.
Radiology · 87d
Cleared Feb 13, 1998
RTR-2000/RTR-4000
K974307
Terarecon,Inc.
Radiology · 88d
Cleared Dec 22, 1997
AUKLET CT SCANNER, TSX-003A
K973908
Toshiba America Medical Systems, In.C
Radiology · 69d
Cleared Nov 21, 1997
SMARTVIEW OPTIONS FOR HISPEED CT/I
K973168
GE Medical Systems
Radiology · 88d
Cleared Nov 04, 1997
IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS
K972903
Imatron, Inc.
Radiology · 90d
Cleared Oct 15, 1997
ULTRAFAST CT SCANNER
K972879
Imatron, Inc.
Radiology · 71d
Cleared Oct 08, 1997
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH
K973327
Shimadzu Medical Systems
Radiology · 34d
Cleared Oct 08, 1997
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX
K973329
Shimadzu Medical Systems
Radiology · 34d
Cleared Sep 23, 1997
ADVANTAGE WINDOWS VOLUME RENDERING OPTION
K972399
Ge Medical Systems, Inc.
Radiology · 89d
Cleared Sep 03, 1997
FLY THROUGH
K971717
Siemens Medical Solutions USA, Inc.
Radiology · 117d
Cleared Jul 14, 1997
TARGOBEAM
K970819
Ferguson Medical
Radiology · 131d
Cleared Jun 13, 1997
OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS
K971054
Siemens Medical Solutions USA, Inc.
Radiology · 81d
Cleared May 29, 1997
CARDIAC SCORING FOR CT SCANNERS
K970980
Elscint, Inc.
Radiology · 72d
Cleared May 20, 1997
SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR
K970999
Sony Medical Systems
Radiology · 62d