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
505–528 of 827
Cleared Aug 19, 2005
DVT SCANNER
K051980
Imaging Sciences Intl., Inc.
Radiology · 29d
Cleared Aug 09, 2005
SYNGO CIRCULATION
K052029
Siemens AG Medical Solutions
Radiology · 13d
Cleared Jul 15, 2005
TSX-101A/H AQUILION 64 SP CT SCANNER
K051833
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Jul 14, 2005
CERETOM, MODEL NL3000
K051765
Neurologica Corporation
Radiology · 14d
Cleared Apr 14, 2005
SYNGO BODY PERFUSION-CT
K050867
Siemens AG
Radiology · 8d
Cleared Mar 10, 2005
TSX-201A AQUILION LB CT SCANNER
K050458
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Mar 01, 2005
SOMATOM EMOTION 16
K050297
Siemens Medical Solution, Inc. USA
Radiology · 22d
Cleared Feb 03, 2005
SYNGO INSPACE 4D
K043469
Siemens AG Medical Solutions
Radiology · 49d
Cleared Dec 23, 2004
SOMATOM RESPIRATORY GATING
K043086
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Dec 15, 2004
SOMATOM CARE CONTRAST CT
K043087
Siemens Medical Solutions USA, Inc.
Radiology · 37d
Cleared Nov 18, 2004
PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A
K043111
Toshiba America Medical Systems, In.C
Radiology · 8d
Cleared Nov 08, 2004
SUPERDIMENSION/BRONCHUS
K042438
Superdimension, Ltd.
Radiology · 61d
Cleared Sep 14, 2004
SOMATOM SPIRIT
K042328
Siemens Medical Systems, Inc.
Radiology · 18d
Cleared Sep 08, 2004
BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER
K042293
Philips Medical Systems (Cleveland), Inc.
Radiology · 15d
Cleared Sep 01, 2004
SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE
K042229
Siemens Medical Solution, Inc. USA
Radiology · 15d
Cleared Jul 13, 2004
N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX
K040782
Image Analysis, Inc.
Radiology · 109d
Cleared Jun 22, 2004
VOLUME VIEWER PLUS
K041521
General Electric Medical Systems
Radiology · 14d
Cleared Jun 17, 2004
CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS
K041542
Neusoft Digital Medical Systems Co., Ltd.
Radiology · 9d
Cleared May 27, 2004
CARDIQ ANALYSIS III
K041267
General Electric Medical Systems
Radiology · 15d
Cleared Apr 21, 2004
HITACHI PRESTO
K040902
Hitachi Medical Systems America, Inc.
Radiology · 14d
Cleared Apr 06, 2004
CADIMPLANT
K040224
Praxim, Inc.
Radiology · 64d
Cleared Apr 02, 2004
SOMATOM SENSATION 64 AND SENSATION CARDIAC
K040665
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Mar 22, 2004
SOMATOM PROJECT P30L
K040577
Siemens Medical Systems, Inc.
Radiology · 18d
Cleared Mar 02, 2004
CT-MASS
K033774
Medis Medical Imaging Systems BV
Radiology · 90d