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
457–480 of 822
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 Nov 08, 2005
ILUMA ORTHOCAT/DENTALCAT
K053046
Imtec Corp.
Radiology · 11d
Cleared Oct 28, 2005
STARSPEED SERIES CT SCANNER SYSTEMS
K052855
Ge Healthcare
Radiology · 17d
Cleared Sep 21, 2005
SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600
K052447
Analogic Corp.
Radiology · 14d
Cleared Sep 08, 2005
SOMATOM DEFINITION
K052216
Siemens Medical Systems, Inc.
Radiology · 36d
Cleared Sep 08, 2005
SUPERDIMENSION/BRONCHUS 4.1
K052260
Superdimension, Ltd.
Radiology · 20d
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 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