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
577–600 of 822
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
Cleared Apr 04, 1997
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K970606
GE Medical Systems
Radiology · 45d
Cleared Mar 11, 1997
C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER
K965004
Siemens Medical Solutions USA, Inc.
Radiology · 85d
Cleared Mar 06, 1997
ANATOM 2000
K964890
Analogic Corp.
Radiology · 90d
Cleared Feb 10, 1997
SOMATOM PLUS 4 CT SCANNER
K964747
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared Jan 24, 1997
HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION
K964746
GE Medical Systems
Radiology · 59d
Cleared Jan 17, 1997
XRT-7.0
K964583
Elscint, Inc.
Radiology · 63d
Cleared Jan 10, 1997
PHILIPS TOMOSCAN AV EXPANDER UPGRADE
K964318
Philips Medical Systems North America, Inc.
Radiology · 73d
Cleared Dec 18, 1996
MOBILE CT PROSPEED FAMILY
K963896
GE Medical Systems
Radiology · 82d
Cleared Oct 25, 1996
SLS-CT
K960985
Bio-Imaging Research, Inc.
Radiology · 239d
Cleared Jul 03, 1996
SELECT/SP
K961464
Elscint, Inc.
Radiology · 77d
Cleared Jun 17, 1996
CT PROSPEED CT/I
K961055
GE Medical Systems
Radiology · 91d
Cleared May 14, 1996
VIFS
K955583
Konica Medical Corp.
Radiology · 161d