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..

822
Total
822
Cleared
108d
Avg days
1976
Since
822 devices
481–504 of 822
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 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 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
Cleared Mar 01, 2004
LIGHTSPEED 7.0 CT SCANNER SYSTEM
K040372
Ge Medical Systems, LLC
Radiology · 13d
Cleared Feb 20, 2004
BRAIN PERFUSION OPTION
K033677
Philips Medical Systems (Cleveland), Inc.
Radiology · 88d
Cleared Jan 09, 2004
ACQSIM-MULTISLICE-CT, MODEL 453567042271
K033357
Philips Medical Systems (Cleveland), Inc.
Radiology · 81d
Cleared Dec 23, 2003
SYNGO PERFUSION-CT
K033832
Siemens AG Medical Solutions
Radiology · 13d
Cleared Nov 20, 2003
LIGHTSPEED 6.0 CT SCANNER SYSTEM
K033502
Ge Medical Systems, LLC
Radiology · 15d
Cleared Nov 10, 2003
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
K032475
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Nov 10, 2003
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
K032536
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Nov 10, 2003
TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
K033418
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Oct 30, 2003
ADVANTAGE 4D OPTION
K032915
Ge Medical Systems, LLC
Radiology · 38d
Cleared Oct 29, 2003
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
K033326
Philips Medical Systems, Inc.
Radiology · 13d
Cleared May 22, 2003
AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7
K031469
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared May 06, 2003
CT COLONOGRAPHY
K023943
Ge Medical Systems, Inc.
Radiology · 161d
Cleared May 06, 2003
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH
K030450
J. Morita USA, Inc.
Radiology · 84d
Cleared May 06, 2003
CARD EP
K031261
GE Medical Systems
Radiology · 15d