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
385–408 of 827
Cleared May 03, 2012
GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
K113341
Hitachi Medical Systems America, Inc.
Radiology · 171d
Cleared Apr 13, 2012
CT-GUIDE NEEDLE GUIDANCE SYSTEM
K120300
Activiews, Ltd.
Radiology · 73d
Cleared Apr 13, 2012
SYNGO CT DYNAMIC ANGIO
K120331
Siemens AG Medical Solutions
Radiology · 71d
Cleared Apr 10, 2012
AQUILION CXL
K112989
Toshiba America Medical Systems, In.C
Radiology · 187d
Cleared Apr 10, 2012
AQUILION ONE
K113466
Toshiba Medical Systems Coporation, Japan
Radiology · 140d
Cleared Apr 10, 2012
PEDCAT
K113548
Curvebeam, LLC
Radiology · 131d
Cleared Apr 06, 2012
AQUILION PRIME
K120710
Toshibamedical Systems Corporation
Radiology · 29d
Cleared Jan 26, 2012
AQUILION PRIME
K110066
Toshiba America Medical Systems, In.C
Radiology · 381d
Cleared Dec 29, 2011
SOMATOM DEFINITION FLASH
K113342
Siemens Medical Systems, Inc.
Radiology · 45d
Cleared Nov 22, 2011
SAFIRE
K103424
Siemens Medical Solutions USA, Inc.
Radiology · 365d
Cleared Nov 10, 2011
CT-GUIDE NEEDLE GUIDANCE SYSTEM
K113063
Activiews, Ltd.
Radiology · 27d
Cleared Sep 09, 2011
GE VEO RECONSTRUCTION OPTION
K103489
General Electric Co.
Radiology · 287d
Cleared Aug 25, 2011
AQUILION LB MOVEMENT BASE KIT
K111633
Toshiba America Medical Systems, In.C
Radiology · 73d
Cleared Aug 18, 2011
SYNGO.CT VASCULAR ANALYSIS
K112020
Siemens Medi Cal Solutions, Inc.
Radiology · 35d
Cleared Jul 20, 2011
OPTIMA CT660
K110227
Ge Medical Systems, LLC
Radiology · 176d
Cleared Jun 21, 2011
CT-GUIDE NEEDLE GUIDANCE SYSTEM
K110812
Activiews, Ltd.
Radiology · 90d
Cleared Apr 19, 2011
DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS
K093581
Ge Medical Systems, LLC
Radiology · 517d
Cleared Apr 12, 2011
SYNGO.CT CARDIAC FUNCTION
K110366
Siemens AG
Radiology · 64d
Cleared Apr 08, 2011
SCENARIA WHOLE-BODY X-RAY CT SYSTEM
K101888
Hitachi Medical Systems America, Inc.
Radiology · 275d
Cleared Mar 24, 2011
BODYTOM NL 4000
K102677
Neurologica Corporation
Radiology · 190d
Cleared Mar 11, 2011
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102102
VATECH Co., Ltd.
Radiology · 227d
Cleared Mar 04, 2011
SOMATOM DEFINITION AS
K103127
Siemens Medical Solutions USA, Inc.
Radiology · 133d
Cleared Feb 18, 2011
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102259
VATECH Co., Ltd.
Radiology · 192d
Cleared Feb 11, 2011
SUPERDIMENSION MARKER DELIVERY KIT
K110093
Superdimension, Inc.
Radiology · 30d