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
481–504 of 822
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 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 Nov 29, 1994
MEDRAD COUNTERPOISE SYSTEM
K944983
Medrad, Inc.
Radiology · 49d
Cleared Oct 21, 1994
PHILIPS TOMOSCAN SR5000
K944326
Philips Medical Systems North America, Inc.
Radiology · 53d
Cleared Oct 11, 1994
PHILIPS TOMOSCAN SR 4000
K936272
Philips Medical Systems North America, Inc.
Radiology · 285d
Cleared Sep 20, 1994
SOMATOM PROJECT 059
K941546
Siemens Corp.
Radiology · 173d
Cleared Aug 23, 1994
HISPEED ADVANTAGE II
K940606
GE Medical Systems
Radiology · 194d
Cleared Jul 29, 1994
ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW
K932508
Elscint, Inc.
Radiology · 430d
Cleared Jul 29, 1994
TSX-002A (XVISION) CT SCANNER
K941745
Toshiba America Medical Systems, In.C
Radiology · 113d
Cleared Jul 05, 1994
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF
K935487
Shimadzu Corp.
Radiology · 232d
Cleared May 17, 1994
VOLUMETRIC RENDERING TECHNIQUE OPTION
K923524
Siemens Medical Solutions USA, Inc.
Radiology · 670d
Cleared Apr 07, 1994
COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION
K924985
Siemens Medical Solutions USA, Inc.
Radiology · 553d
Cleared Dec 14, 1993
IMPAX 3000
K934832
Heraeus Kulzer, Inc.
Radiology · 67d
Cleared Mar 19, 1993
HELICAT
K930090
Elscint, Inc.
Radiology · 70d
Cleared Mar 10, 1993
PHILIPS TOMOSCAN SR7000 CT SYSTEMS
K924082
Philips Medical Systems, Inc.
Radiology · 209d
Cleared Feb 02, 1993
ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION
K923077
GE Medical Systems
Radiology · 222d
Cleared Oct 20, 1992
CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM
K921192
GE Medical Systems
Radiology · 222d