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
553–576 of 822
Cleared Jun 08, 1999
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION
K991553
Shimadzu Corp.
Radiology · 36d
Cleared May 13, 1999
PHILIPS TOMOSCAN AV-NT
K991278
Philips Medical Systems North America, Inc.
Radiology · 29d
Cleared May 12, 1999
CALCIUM SCORING
K990426
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Apr 21, 1999
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION
K984156
Shimadzu Medical Systems
Radiology · 153d
Cleared Mar 19, 1999
MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI)
K990134
Toshiba America Medical Systems, In.C
Radiology · 64d
Cleared Mar 12, 1999
3D-ANGIO
K984634
Siemens Medical Corp.
Radiology · 72d
Cleared Nov 24, 1998
PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE
K982536
Siemens Corp.
Radiology · 126d
Cleared Nov 19, 1998
FACTS
K982010
Philips Medical Systems (Cleveland), Inc.
Radiology · 164d
Cleared Nov 04, 1998
CT BIOPSYVIEW
K983140
Philips Medical Systems North America, Inc.
Radiology · 57d
Cleared Oct 21, 1998
ASTEION CT SCANNER, TSX-021A
K982787
Toshiba America Medical Systems, In.C
Radiology · 72d
Cleared Oct 06, 1998
PHILIPS TOMOSCAN CS
K982631
Philips Medical Systems, Inc.
Radiology · 70d
Cleared Oct 05, 1998
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL
K982583
Shimadzu Corp.
Radiology · 73d
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