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
145–168 of 819
Cleared Dec 10, 2020
Deep Learning Image Reconstruction for Gemstone Spectral Imaging
K201745
Ge Medical Systems, LLC
Radiology · 167d
Cleared Dec 10, 2020
Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I
K203042
Canon Medical Systems Corporation
Radiology · 65d
Cleared Nov 25, 2020
The Multimodality Advanced Vessel Analysis
K203216
Philips Medical Systems Nederland B.V.
Radiology · 23d
Cleared Nov 20, 2020
Revolution Ascend
K203169
Ge Healthcare Japan Corporation
Radiology · 28d
Cleared Nov 18, 2020
HiRise
K203187
Curvebeam, LLC
Radiology · 22d
Cleared Nov 12, 2020
FastStroke, CT Perfusion 4D
K193289
GE Medical Systems SCS
Radiology · 351d
Cleared Oct 29, 2020
LSN
K201092
Imaging Biometrics, LLC
Radiology · 189d
Cleared Oct 11, 2020
syngo.CT Neuro Perfusion
K202213
Siemens Medical Solutions USA, Inc.
Radiology · 66d
Cleared Sep 30, 2020
Clear Guide SCENERGY
K201188
Clear Guide Medical
Radiology · 152d
Cleared Aug 07, 2020
VIDAvision
K200990
Vida Diagnostics, Inc.
Radiology · 114d
Cleared Jul 31, 2020
Clear Guide SCENERGY
K201898
Clear Guide Medical
Radiology · 29d
Cleared Jul 22, 2020
SOMATOM On.site and On.scene
K193277
Siemens Medical Solutions USA, Inc.
Radiology · 238d
Cleared Jul 17, 2020
SCENARIA View
K200498
Hitachi Healthcare Americas
Radiology · 140d
Cleared Jul 09, 2020
XACT Robotic System
K201586
Xact Robotics, Ltd.
Radiology · 28d
Cleared Jul 06, 2020
Deep Recon
K193073
Shanghai United Imaging Healthcare Co., Ltd.
Radiology · 245d
Cleared May 14, 2020
XV Lung Ventilation Analysis Software
K193293
4Dx Limited
Radiology · 169d
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