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
385–408 of 822
Cleared Feb 20, 2004
BRAIN PERFUSION OPTION
K033677
Philips Medical Systems (Cleveland), Inc.
Radiology · 88d
Cleared Jan 09, 2004
ACQSIM-MULTISLICE-CT, MODEL 453567042271
K033357
Philips Medical Systems (Cleveland), Inc.
Radiology · 81d
Cleared Nov 20, 2003
LIGHTSPEED 6.0 CT SCANNER SYSTEM
K033502
Ge Medical Systems, LLC
Radiology · 15d
Cleared Nov 10, 2003
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
K032475
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Nov 10, 2003
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
K032536
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Nov 10, 2003
TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
K033418
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Oct 30, 2003
ADVANTAGE 4D OPTION
K032915
Ge Medical Systems, LLC
Radiology · 38d
Cleared Oct 29, 2003
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
K033326
Philips Medical Systems, Inc.
Radiology · 13d
Cleared May 22, 2003
AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7
K031469
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared May 06, 2003
CT COLONOGRAPHY
K023943
Ge Medical Systems, Inc.
Radiology · 161d
Cleared May 06, 2003
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH
K030450
J. Morita USA, Inc.
Radiology · 84d
Cleared May 06, 2003
CARD EP
K031261
GE Medical Systems
Radiology · 15d
Cleared Mar 10, 2003
LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM
K030420
GE Medical Systems
Radiology · 28d
Cleared Feb 10, 2003
LUNG NODULE ASSESSMENT AND COMPARISON OPTION
K023785
Philips Medical Systems (Cleveland), Inc.
Radiology · 90d
Cleared Nov 22, 2002
CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B
K023760
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Oct 23, 2002
LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW
K023332
GE Medical Systems
Radiology · 16d
Cleared Sep 19, 2002
SMART BREATH RESPIRATORY COMPENSATION OPTION
K022919
GE Medical Systems
Radiology · 15d
Cleared Jul 16, 2002
LUNGCARE CT SOFTWARE PACKAGE
K022013
Siemens Medical Solutions USA, Inc.
Radiology · 26d
Cleared Jul 09, 2002
CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI)
K022050
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared May 22, 2002
HISPEED DUAL
K021491
Ge Medical Systems, Inc.
Radiology · 13d
Cleared Apr 03, 2002
SMARTSCORE 3.5
K020929
GE Medical Systems
Radiology · 12d
Cleared Mar 26, 2002
CARD IQ ANALYSIS II
K020796
GE Medical Systems
Radiology · 14d
Cleared Mar 22, 2002
PRONTO
K014240
Hitachi Medical Systems America, Inc.
Radiology · 86d
Cleared Feb 15, 2002
CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A
K020385
Toshiba America Medical Systems, In.C
Radiology · 10d