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Panels › Radiology › Product code JAK · Class 2

System, X-Ray, Tomography, Computed

Regulation 892.1750

22510(k)s in 12 months (827 all time)
38recalls in 12 months (872 all time)
795recalls that name a 510(k)
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Top companies in JAK

DateFirm and productCodeLinked 510(k)
Jan 18, 2017Philips Electronics North America Corporation
Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ra
Terminated
JAKNone listed
Jan 18, 2017Philips Electronics North America Corporation
Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray
Terminated
JAKNone listed
Jan 18, 2017Philips Electronics North America Corporation
Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of
Terminated
JAKNone listed
Dec 23, 2016Philips Medical Systems (Cleveland) Inc
Brilliance iCT
Terminated
JAKK060937
Dec 16, 2016Philips Medical Systems (Cleveland) Inc
IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstructio
Terminated
JAKK133674
Dec 2, 2016Siemens Medical Solutions USA, Inc
SOMATOM Force, System x-ray, tomography, computed
Terminated
JAKK133589
Nov 25, 2016Philips Medical Systems (Cleveland) Inc
Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles
Terminated
JAKK060937
Nov 22, 2016Siemens Medical Solutions USA, Inc
SOMATOM Perspective, Computed tomography x-ray system
Terminated
JAKK151765
Nov 22, 2016Siemens Medical Solutions USA, Inc
SOMATOM Scope Power, Computed tomography x-ray system
Terminated
JAKK151749
Nov 22, 2016Siemens Medical Solutions USA, Inc
SOMATOM Scope, Computed tomography x-ray system
Terminated
JAKK151749
Nov 18, 2016Toshiba American Medical Systems Inc
Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstructi
Terminated
JAKK141741
Nov 17, 2016Siemens Medical Solutions USA, Inc
SOMATOM Definition Flash, Computed tomography system Product Usage: SOMATOM Definition AS systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transm
Terminated
JAKK121072
Nov 17, 2016Siemens Medical Solutions USA, Inc
SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM Definition Flash systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transm
Terminated
JAKK143400
Nov 15, 2016Siemens Medical Solutions USA, Inc
SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plan
Terminated
JAKK152036
Nov 15, 2016Siemens Medical Solutions USA, Inc
SOMATOM Definition Flash System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial pla
Terminated
JAKK143416
Nov 15, 2016Siemens Medical Solutions USA, Inc
SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane
Terminated
JAKK152036
Nov 14, 2016Philips Medical Systems (Cleveland) Inc
Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body mat
Terminated
JAKK150665
Nov 14, 2016Philips Medical Systems (Cleveland) Inc
IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes
Terminated
JAKK133674
Nov 12, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Terminated
JAKK160743
Nov 12, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128 728323
Terminated
JAKK160743
Nov 12, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and plane
Terminated
JAKK160743
Nov 12, 2016Philips Medical Systems (Cleveland) Inc
Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
Terminated
JAKK033326
Nov 12, 2016Philips Medical Systems (Cleveland) Inc
Brilliance 64 728231 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
Terminated
JAKK033326
Nov 8, 2016Siemens Medical Solutions USA, Inc
SOMATOM Definition Flash system, x-ray, tomography, computed
Terminated
JAKK143416
Nov 8, 2016Siemens Medical Solutions USA, Inc
SOMATOM Definition AS system, x-ray, tomography, computed
Terminated
JAKK143409
Nov 2, 2016Siemens Medical Solutions USA, Inc
SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstru
Terminated
JAKK143416
Nov 2, 2016Siemens Medical Solutions USA, Inc
SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruc
Terminated
JAKK152036
Nov 2, 2016Siemens Medical Solutions USA, Inc
SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstructi
Terminated
JAKK152036
Oct 13, 2016Philips Medical Systems (Cleveland) Inc
IQon Spectral CT Computed Tomography X-ray system, Model 728332
Terminated
JAKK133674
Oct 13, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core Computed Tomography X-ray system, Model 728321
Terminated
JAKK160743
Oct 13, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray system, Model 728323
Terminated
JAKK160743
Oct 13, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity CT Computed Tomography X-ray system, Model 728326
Terminated
JAKK160743
Oct 13, 2016Philips Medical Systems (Cleveland) Inc
Brilliance ICT SP Computed Tomography X-ray system, Model 728311
Terminated
JAKK060937
Oct 13, 2016Philips Medical Systems (Cleveland) Inc
Brilliance iCT Computed Tomography X-ray system, Model 728306
Terminated
JAKK060937
Oct 6, 2016Toshiba American Medical Systems Inc
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Terminated
JAKNone listed
Oct 6, 2016Toshiba American Medical Systems Inc
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the h
Terminated
JAKNone listed
Oct 6, 2016Toshiba American Medical Systems Inc
Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
Terminated
JAKNone listed
Aug 31, 2016Neusoft Medical Systems Co., Ltd.
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06 or previous version
Terminated
JAKK121792
Aug 31, 2016Neusoft Medical Systems Co., Ltd.
NeuViz 64 Multi-slice CT Scanner Systems
Terminated
JAKK121792
Aug 24, 2016Philips Medical Systems
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at
Terminated
JAKK033326
Aug 24, 2016Philips Medical Systems
Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data ta
Terminated
JAKK033326
Aug 24, 2016Philips Medical Systems
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken a
Terminated
JAKK033326
Aug 24, 2016Philips Medical Systems
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data take
Terminated
JAKK033326
Aug 23, 2016Siemens Medical Solutions USA, Inc
SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system
Terminated
JAKK143401
Aug 23, 2016Siemens Medical Solutions USA, Inc
SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system
Terminated
JAKK143416
Aug 23, 2016Siemens Medical Solutions USA, Inc
SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system
Terminated
JAKK143409
Jul 20, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data ta
Terminated
JAKK033326
Jul 20, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core, Model number 728321 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken
Terminated
JAKK033326
Jul 20, 2016Philips Medical Systems (Cleveland) Inc
Brilliance CT 16 Power, Model number 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission da
Terminated
JAKK012009
Jul 20, 2016Philips Medical Systems (Cleveland) Inc
Brilliance 16, Model number 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken
Terminated
JAKK012009

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