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
313–336 of 827
Cleared Mar 19, 2015
Aquilion LB, TSX-201A/3, V6.0
K150003
Toshibamedical Systems Corporation
Radiology · 76d
Cleared Mar 10, 2015
Aquilion ONE Vision, v7.0
K142465
Toshibamedical Systems Corporation
Radiology · 189d
Cleared Jan 26, 2015
NewTom 5G
K142222
Qr S.R.L.
Radiology · 166d
Cleared Jan 16, 2015
iMAR
K142584
Siemens Medical Solutions USA, Inc.
Radiology · 123d
Cleared Jan 12, 2015
CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT
K143223
Toshibamedical Systems Corporation
Radiology · 63d
Cleared Dec 23, 2014
NExCT 7
K142697
Neurologica Corporation
Radiology · 92d
Cleared Dec 03, 2014
CLEARVIEW
K133373
Neusoft Medical Systems Co., Ltd.
Radiology · 397d
Cleared Nov 26, 2014
AQUILION PRIME, V6.00
K141741
Toshibamedical Systems Corporation
Radiology · 152d
Cleared Nov 21, 2014
PHILIPS IQON SPECTRAL CT
K133674
Philips Healthcare (Cleveland)
Radiology · 357d
Cleared Nov 13, 2014
SYNGO, CT LIVER ANALYSIS
K133643
Siemens Medi Cal Solutions, Inc.
Radiology · 351d
Cleared Oct 16, 2014
SYNGO CT SINGLE SOURCE DUAL ENERGY
K133677
Siemens Medical Solutions USA, Inc.
Radiology · 321d
Cleared Sep 25, 2014
PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION
K133603
Philips Medical Systems
Radiology · 304d
Cleared Sep 17, 2014
Lung Density Analysis
K141069
Imbio, LLC
Radiology · 146d
Cleared Sep 15, 2014
SOMATOM SCOPE/SOMATOM SCOPE POWER
K140912
Siemens Medical Solutions USA, Inc.
Radiology · 159d
Cleared Sep 05, 2014
SURESUBTRACTION LUNG
K133324
Toshiba Medical Systems Corporation, Japan
Radiology · 311d
Cleared Sep 05, 2014
AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT
K134025
Toshibamedical Systems Corporation
Radiology · 249d
Cleared Aug 14, 2014
SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT
K140232
Siemens Medical Solutions USA, Inc.
Radiology · 196d
Cleared Jul 07, 2014
SYNGO, CT DUAL ENERGY
K133648
Siemens Medical Solutions USA, Inc.
Radiology · 222d
Cleared Jun 27, 2014
PARI-PATH SURGICAL NAVIGATION SYSTEM
K133901
Paritic, Inc.
Radiology · 189d
Cleared Jun 20, 2014
ADMIRE
K133646
Siemens Medical Systems, Inc.
Radiology · 205d
Cleared Jun 13, 2014
CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION
K132524
Philips Medical Systems
Radiology · 305d
Cleared May 19, 2014
MAXIO
K132108
Perfint Healthcare Pvt, Ltd.
Radiology · 315d
Cleared Apr 30, 2014
SOMATOM PERSPECTIVE
K133590
Siemens Medical Solutions USA, Inc.
Radiology · 159d
Cleared Apr 22, 2014
HEPATIC VCAR
K133649
GE Medical Systems SCS
Radiology · 146d