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., General Electric Co. and Canon Medical Systems Corporation.

819
Total
819
Cleared
107d
Avg days
1976
Since
819 devices
217–240 of 819
Cleared Mar 21, 2018
SOMATOM Edge Plus
K173607
Siemens Medical Solutions USA, Inc.
Radiology · 120d
Cleared Mar 20, 2018
Philips Incisive CT
K180015
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 77d
Cleared Mar 15, 2018
AIRO Computed Tomography (CT) X-ray System
K180393
Mobius Imaging, LLC
Radiology · 30d
Cleared Mar 08, 2018
syngo.CT Clinical Extensions
K173625
Siemens Medical Solutions USA, Inc.
Radiology · 104d
Cleared Mar 02, 2018
uCT Computed Tomography X-ray System
K172135
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 231d
Cleared Feb 23, 2018
Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0
K173468
Toshibamedical Systems Corporation
Radiology · 107d
Cleared Feb 13, 2018
CT6485, CT12885
K172058
Analogic Corporation
Radiology · 222d
Cleared Feb 08, 2018
superDimension Navigation System V7.2
K173244
Covidien, LLC
Radiology · 125d
Cleared Jan 19, 2018
OnSight 3D Extremity System
K173478
Carestream Health, Inc.
Radiology · 67d
Cleared Nov 09, 2017
Philips CT Big Bore
K171850
Philips Medical Systems (Cleveland), Inc.
Radiology · 141d
Cleared Jun 30, 2017
Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1
K170177
Toshibamedical Systems Corporation
Radiology · 162d
Cleared Apr 07, 2017
Philips iCT CT System
K162838
Philips Medical Systems (Cleveland), Inc.
Radiology · 178d
Cleared Apr 05, 2017
IQon Spectral CT
K163711
Philips Medical Systems (Cleveland), Inc.
Radiology · 96d
Cleared Mar 24, 2017
Scan&GO
K163297
Siemens Medical Solutions USA, Inc.
Radiology · 122d
Cleared Mar 21, 2017
SOMATOM go.Up, SOMATOM go.Now
K163296
Siemens Medical Solutions USA, Inc.
Radiology · 119d
Cleared Mar 03, 2017
HITACHI Supria Whole-body X-ray CT System Phase 3
K163528
Hitachi Medical Systems America, Inc.
Radiology · 77d
Cleared Mar 01, 2017
syngo. CT Neuro Perfusion
K163284
Siemens Medical Solutions USA, Inc.
Radiology · 99d
Cleared Feb 09, 2017
syngo.CT Extended Functionality
K163341
Siemens Medical Solutions USA, Inc.
Radiology · 72d
Cleared Feb 02, 2017
Aquilion Lightning, TSX-036A/1, V8.4
K170019
Toshibamedical Systems Corporation
Radiology · 30d
Cleared Dec 16, 2016
Somatom Confidence ® RT Pro
K162302
Siemens Medical Solutions USA, Inc.
Radiology · 121d
Cleared Aug 24, 2016
SOMATOM Drive
K161196
Siemens Medical Solutions USA, Inc.
Radiology · 119d
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