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
601–624 of 827
Cleared May 12, 2000
PHILIPS CT SECURA MV
K000819
Philips Medical Systems North America, Inc.
Radiology · 60d
Cleared Mar 23, 2000
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES
K994431
Shimadzu Medical Systems
Radiology · 84d
Cleared Mar 17, 2000
EBT ULTRAFAST CT SCANNER SYSTEM
K000359
Imatron, Inc.
Radiology · 42d
Cleared Feb 15, 2000
LIGHTSPEED 2.0CT SCANNER SYSTEM
K000300
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Dec 21, 1999
CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM
K993645
Ge Medical Systems, Inc.
Radiology · 54d
Cleared Nov 24, 1999
CT PERFUSION OPTION
K993791
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Nov 24, 1999
SMART VESSEL ANALYSIS (SMART VA) OPTION
K993792
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Nov 09, 1999
EBT ULTRAFAST CT SCANNER SYSTEM
K992740
Imatron, Inc.
Radiology · 85d
Cleared Aug 17, 1999
SOMATOM PROJECT 10-CT SCANNERS
K991764
Siemens Medical Solutions USA, Inc.
Radiology · 85d
Cleared Aug 10, 1999
ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A
K991766
Toshiba America Medical Systems, In.C
Radiology · 78d
Cleared Jun 18, 1999
HISPEED NX/I CT SCANNER SYSTEM
K991716
Ge Medical Systems, Inc.
Radiology · 29d
Cleared Jun 09, 1999
SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION
K991600
Siemens Corp.
Radiology · 30d
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