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
Cleared
Aug 08, 2016
P-ARTIS
P-Cure, Ltd.
Radiology
158d
Cleared
Aug 08, 2016
Philips Ingenuity CT
Philips Medical Systems (Cleveland), Inc.
Radiology
144d
Cleared
Jul 22, 2016
Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4
Toshibamedical Systems Corporation
Radiology
102d
Cleared
Jun 29, 2016
ADMIRE
Siemens Medi Cal Solutions, Inc.
Radiology
222d
Cleared
Jun 29, 2016
Ablation Confirmation
Neuwave Medical, Inc.
Radiology
51d
Cleared
Jun 16, 2016
ECG CT Gating Device
Neocoil, LLC
Radiology
129d
Cleared
Jun 09, 2016
Aquilion ONE (TSX-305A/3) V7.3
Toshibamedical Systems Corporation
Radiology
100d
Cleared
May 17, 2016
SafeCT-29
Medic Vision Imaging Solutions
Radiology
180d
Cleared
Apr 19, 2016
AIRO Computed Tomography (CT) X-ray System
Mobius Imaging
Radiology
90d
Cleared
Apr 08, 2016
Philips Multislice CT System with Low Dose CT Lung Cancer
Philips Medical Systems (Cleveland), Inc.
Radiology
133d
Cleared
Apr 01, 2016
Aquilion Lightning, TSX-035A/4 and /5, V7.0
Toshibamedical Systems Corporation
Radiology
143d
Cleared
Mar 25, 2016
SOMATOM Perspective
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)
Siemens Medical Solutions USA, Inc.
Radiology
263d
Cleared
Mar 09, 2016
SmartView 3D Option
Ge Hangwei Medical System Co., Ltd.
Radiology
105d
Cleared
Feb 19, 2016
syngo.CT Single Source Dual Energy (Twin Beam)
Siemens Medical Solutions USA, Inc.
Radiology
105d
Cleared
Feb 12, 2016
Clear Guide SCENERGY
Clear Guide Medical
Radiology
122d
Cleared
Jan 20, 2016
CAS-One IR
Cascination AG
Radiology
142d
Cleared
Jan 20, 2016
Stroke VCAR
GE Medical Systems SCS
Radiology
132d
Cleared
Nov 27, 2015
Aquilion ONE Vision with FIRST 1.0 (CCRS-001A)
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
Siemens Medical Solutions USA, Inc.
Radiology
406d
Cleared
Nov 20, 2015
IQQA Guide
Edda Technology
Radiology
177d
Cleared
Nov 12, 2015
SOMATOM Emotion 6/16
Siemens Medical Solutions USA, Inc.
Radiology
136d
Cleared
Nov 05, 2015
superDimension Navigation System
Covidien, LLC
Radiology
167d
Cleared
Nov 04, 2015
NeuViz 128 Multi-slice CT Scanner System
Neusoft Medical Systems Co., Ltd.
Radiology
166d