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
169–192 of 819
Cleared Feb 25, 2020
uCT 530, uCT 550
K200016
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 53d
Cleared Feb 21, 2020
Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
K192832
Canon Medical Systems Corporation
Radiology · 142d
Cleared Feb 13, 2020
Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System
K192828
Canon Medical Systems Corporation
Radiology · 134d
Cleared Jan 24, 2020
IQon Spectral CT
K193454
Philips Medical Systems Nederland B.V.
Radiology · 42d
Cleared Jan 16, 2020
Auto Positioning
K192956
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 87d
Cleared Dec 17, 2019
syngo.CT CaScoring
K192763
Siemens Medical Solutions USA, Inc.
Radiology · 78d
Cleared Dec 13, 2019
Deep Learning Image Reconstruction
K193170
Ge Healthcare Japan Corporation
Radiology · 28d
Cleared Nov 21, 2019
SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO
K192061
Siemens Medical Solutions USA, Inc.
Radiology · 112d
Cleared Nov 06, 2019
SOMATOM X.cite
K191891
Siemens Medical Solutions USA, Inc.
Radiology · 114d
Cleared Oct 24, 2019
Revolution Maxima, Revolution Ace
K192686
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 28d
Cleared Oct 03, 2019
XACT Robotic System
K191332
Xact Robotics, Ltd.
Radiology · 140d
Cleared Oct 03, 2019
Ablation Confirmation
K192427
Neuwave Medical, Inc.
Radiology · 28d
Cleared Sep 20, 2019
syngo.CT Extended Functionality
K192402
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Sep 13, 2019
SCENARIA View
K190841
Hitachi Healthcare Americas
Radiology · 165d
Cleared Sep 10, 2019
AI-Rad Companion (Cardiovascular)
K183268
Siemens Medical Solutions USA, Inc.
Radiology · 291d
Cleared Sep 06, 2019
Aquilion ONE (TSX-306A/3) V10.0
K192188
Canon Medical Systems Corporation
Radiology · 24d
Cleared Aug 07, 2019
ILLUMISITE Platform
K191394
Covidien, LLC
Radiology · 75d
Cleared Jul 29, 2019
Access CT
K191136
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 91d
Cleared Jul 26, 2019
AI-Rad Companion (Pulmonary)
K183271
Siemens Medical Solutions USA, Inc.
Radiology · 245d
Cleared Jul 26, 2019
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
K191777
Ge Medical Systems, LLC
Radiology · 24d
Cleared Jul 05, 2019
Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE
K182901
Canon Medical Systems Corporation
Radiology · 262d
Cleared Jul 03, 2019
syngo.CT Dual Energy
K191468
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Jun 27, 2019
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence
K190578
Siemens Medical Solutions USA, Inc.
Radiology · 113d
Cleared Jun 12, 2019
Aquilion ONE (TSX-305A/6) V8.9 with AiCE
K183046
Canon Medical Systems Corporation
Radiology · 222d