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
169–192 of 827
Cleared May 14, 2020
Syngo.CT CaScoring
K201034
Siemens Medical Solutions USA, Inc.
Radiology · 24d
Cleared May 14, 2020
PercuNav Image Fusion and Interventional Navigation
K201053
Philips Ultrasound, Inc.
Radiology · 23d
Cleared Apr 01, 2020
SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO
K200524
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Mar 25, 2020
syngo.CT Cardiac Planning
K200515
Siemens Medical Soultions USA, Inc.
Radiology · 23d
Cleared Mar 20, 2020
Hepatic VCAR
K193281
GE Medical Systems SCS
Radiology · 114d
Cleared Mar 16, 2020
Al-Rad Companion (Musculoskeletal)
K193267
Siemens Medical Solutions USA, Inc.
Radiology · 111d
Cleared Mar 05, 2020
CURA 778
K192590
Fmi Medical Systems, Inc.
Radiology · 167d
Cleared Mar 04, 2020
Broncholab
K191550
Fluidda, Inc.
Radiology · 266d
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