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
649–672 of 827
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
Cleared Apr 15, 1996
REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A
K950972
Toshiba America Medical Systems, In.C
Radiology · 410d
Cleared Apr 03, 1996
PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMS
K960635
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Feb 09, 1996
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX
K955255
Shimadzu Medical Systems
Radiology · 88d
Cleared Jan 30, 1996
PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM
K955268
Philips Medical Systems (Cleveland), Inc.
Radiology · 74d
Cleared Jan 26, 1996
SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH
K955253
Shimadzu Medical Systems
Radiology · 74d
Cleared Jan 26, 1996
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TC
K955254
Shimadzu Medical Systems
Radiology · 74d
Cleared Oct 19, 1995
DPX TISSUE QUANTIFICATION OUTPUT
K935454
Lunar Corp.
Radiology · 706d
Cleared Oct 07, 1995
PHILIPS TOMOSCAN SR 8000
K954255
Philips Medical Systems North America, Inc.
Radiology · 26d
Cleared Apr 27, 1995
PQ5000 CT SYSTEM
K943623
Philips Medical Systems (Cleveland), Inc.
Radiology · 275d
Cleared Mar 14, 1995
HRSW OPTION FOR CT TWIN FLASH
K945512
Elscint, Inc.
Radiology · 125d
Cleared Feb 07, 1995
CT PROSPEED FAMILY
K944013
GE Medical Systems
Radiology · 175d
Cleared Jan 25, 1995
ANATOM 2000
K944131
Analogic Corp.
Radiology · 154d