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
529–552 of 827
Cleared Mar 01, 2004
LIGHTSPEED 7.0 CT SCANNER SYSTEM
K040372
Ge Medical Systems, LLC
Radiology · 13d
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 Dec 23, 2003
SYNGO PERFUSION-CT
K033832
Siemens AG Medical Solutions
Radiology · 13d
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
MEDICHEART, MODEL RELEASE 1
K032823
Medicsight
Radiology · 61d
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 Nov 05, 2003
MEDIC COLON MODEL, RELEASE 1
K033102
Medicsight
Radiology · 37d
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 Oct 02, 2003
MINICAT DENTOCAT
K032243
Xoran Technologies, Inc.
Radiology · 72d
Cleared Jun 20, 2003
AUTOBONE
K031871
Ge Medical Systems Europe
Radiology · 3d
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 21, 2003
RADIOMED SOFT TISSUE MARKER
K031206
Radiomed Corp.
Radiology · 35d
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 Mar 04, 2003
VIDAR BONE TRACK SYSTEM SOFTWARE
K024171
Vidar Systems Corp.
Radiology · 76d
Cleared Feb 21, 2003
PRIMELUNG
K024149
Accuimage Diagnostics Corp.
Radiology · 67d
Cleared Feb 10, 2003
LUNG NODULE ASSESSMENT AND COMPARISON OPTION
K023785
Philips Medical Systems (Cleveland), Inc.
Radiology · 90d
Cleared Jan 31, 2003
RADIOMED MARKER
K022326
Radiomed Corporation
Radiology · 197d