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
241–264 of 822
Cleared Nov 03, 2016
Vitrea CT Dual Energy Image View
K161157
Vital Images, Inc.
Radiology · 192d
Cleared Aug 30, 2016
OnSight 3D Extremity System
K160723
Carestream Health, Inc.
Radiology · 167d
Cleared Aug 24, 2016
SOMATOM Drive
K161196
Siemens Medical Solutions USA, Inc.
Radiology · 119d
Cleared Aug 17, 2016
SUPRIA w/guideShot Option
K161748
Hitachi Medical Systems America, Inc.
Radiology · 54d
Cleared Aug 08, 2016
Philips Ingenuity CT
K160743
Philips Medical Systems (Cleveland), Inc.
Radiology · 144d
Cleared Jul 22, 2016
Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4
K161009
Toshibamedical Systems Corporation
Radiology · 102d
Cleared Jun 09, 2016
Aquilion ONE (TSX-305A/3) V7.3
K160587
Toshibamedical Systems Corporation
Radiology · 100d
Cleared Apr 08, 2016
Philips Multislice CT System with Low Dose CT Lung Cancer
K153444
Philips Medical Systems (Cleveland), Inc.
Radiology · 133d
Cleared Apr 01, 2016
Aquilion Lightning, TSX-035A/4 and /5, V7.0
K153263
Toshibamedical Systems Corporation
Radiology · 143d
Cleared Mar 25, 2016
SOMATOM Perspective
K151765
Siemens Medical Solutions USA, Inc.
Radiology · 269d
Cleared Mar 18, 2016
somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version)
K151749
Siemens Medical Solutions USA, Inc.
Radiology · 263d
Cleared Feb 19, 2016
syngo.CT Single Source Dual Energy (Twin Beam)
K153220
Siemens Medical Solutions USA, Inc.
Radiology · 105d
Cleared Jan 20, 2016
Stroke VCAR
K152584
GE Medical Systems SCS
Radiology · 132d
Cleared Nov 27, 2015
Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)
K151673
Toshibamedical Systems Corporation
Radiology · 158d
Cleared Nov 24, 2015
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power
K142955
Siemens Medical Solutions USA, Inc.
Radiology · 406d
Cleared Nov 12, 2015
SOMATOM Emotion 6/16
K151752
Siemens Medical Solutions USA, Inc.
Radiology · 136d
Cleared Nov 05, 2015
superDimension Navigation System
K151376
Covidien, LLC
Radiology · 167d
Cleared Nov 02, 2015
syngo.CT Myocardial Perfusion
K150713
Siemens Medical Solutions USA, Inc.
Radiology · 228d
Cleared Oct 30, 2015
SCENARIA Phase 3 Whole-body X-ray CT System
K150595
Hitachi Medical Systems America, Inc.
Radiology · 235d
Cleared Oct 30, 2015
Lung Analysis Software
K151283
Vital Images, Inc.
Radiology · 169d
Cleared Oct 10, 2015
Vitrea CT Lung Density Analysis Software
K151919
Vital Images, Inc.
Radiology · 89d
Cleared Oct 09, 2015
Aquilion Lightning (TSX-035A/2, V7.0)
K151833
Toshibamedical Systems Corporation
Radiology · 95d
Cleared Oct 09, 2015
SOMATOM Definition Edge, SOMATOM Definition AS/AS+
K152036
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Sep 30, 2015
Supria Whole-body X-ray CT System
K150565
Hitachi Medical Systems America, Inc.
Radiology · 208d