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
361–384 of 822
Cleared Nov 03, 2006
TSX-301A, AQUILION ONE CT SYSTEM
K063189
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 02, 2006
EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900
K063029
E-Z-Em, Inc.
Radiology · 31d
Cleared Oct 05, 2006
SYNGO DUAL ENERGY
K062351
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared Jul 12, 2006
LIGHTSPEED 7.1 CT SCANNER SYSTEM
K061817
Ge Medical Systems, LLC
Radiology · 14d
Cleared Jun 26, 2006
AUTOBONE2
K061625
Ge Healthcare
Radiology · 14d
Cleared Jun 05, 2006
BRILLIANCE VOLUME
K060937
Philips Medical Systems (Cleveland), Inc.
Radiology · 61d
Cleared May 30, 2006
CARDIQ FUSION
K061370
Ge Healthcare
Radiology · 13d
Cleared May 12, 2006
TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING
K061187
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Apr 19, 2006
GE LIGHTSPEED XTRA CT SCANNER SYSTEM
K060052
Ge Medical Systems, LLC
Radiology · 103d
Cleared Apr 05, 2006
ADVANCE VESSEL ANALYSIS II
K060779
Ge Healthcare
Radiology · 14d
Cleared Mar 10, 2006
CT PERFUSION 4
K052839
Ge Healthcare
Radiology · 154d
Cleared Feb 17, 2006
CXR16
K053148
Hitachi Medical Systems America, Inc.
Radiology · 99d
Cleared Dec 27, 2005
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1 EXF
K052587
J. Morita USA, Inc.
Radiology · 98d
Cleared Oct 28, 2005
STARSPEED SERIES CT SCANNER SYSTEMS
K052855
Ge Healthcare
Radiology · 17d
Cleared Aug 25, 2005
INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ
K052157
Ge Medical Systems, LLC
Radiology · 17d
Cleared Jul 15, 2005
TSX-101A/H AQUILION 64 SP CT SCANNER
K051833
Toshiba America Medical Systems, In.C
Radiology · 9d
Cleared Mar 10, 2005
TSX-201A AQUILION LB CT SCANNER
K050458
Toshiba America Medical Systems, In.C
Radiology · 15d
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 Sep 08, 2004
BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER
K042293
Philips Medical Systems (Cleveland), Inc.
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 01, 2004
LIGHTSPEED 7.0 CT SCANNER SYSTEM
K040372
Ge Medical Systems, LLC
Radiology · 13d