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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)
Feb 15, 2016Siemens Medical Solutions USA, Inc
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either th
Terminated
JAKK013522
Feb 15, 2016Siemens Medical Solutions USA, Inc
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either th
Terminated
JAKK133424
Feb 15, 2016Siemens Medical Solutions USA, Inc
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either th
Terminated
JAKK050297
Feb 15, 2016Siemens Medical Solutions USA, Inc
Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either th
Terminated
JAKK023687
Feb 10, 2016GE Medical Systems, LLC
LightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST sy
Terminated
JAKK030420
Feb 10, 2016GE Medical Systems, LLC
LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Dis
Terminated
JAKK013561
Feb 5, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity CT 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
Feb 5, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128 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
Feb 5, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core 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
Feb 5, 2016Philips Medical Systems (Cleveland) Inc
Brilliance iCT SP 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
JAKK060937
Feb 5, 2016Philips Medical Systems (Cleveland) Inc
Brilliance iCT 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
JAKK060937
Feb 5, 2016Philips Medical Systems (Cleveland) Inc
Brilliance 64: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
Jan 21, 2016Siemens Medical Solutions USA, Inc.
The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomog
Terminated
JAKK142006
Dec 24, 2015Philips Medical Systems (Cleveland) Inc
Ingenuity CT Computed Tomography X-ray system
Terminated
JAKK033326
Dec 24, 2015Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray system
Terminated
JAKK033326
Dec 24, 2015Philips Medical Systems (Cleveland) Inc
Ingenuity Core Computed Tomography X-ray system
Terminated
JAKK033326
Dec 24, 2015Philips Medical Systems (Cleveland) Inc
Brilliance iCT SP Computed Tomography X-ray system
Terminated
JAKK060937
Dec 24, 2015Philips Medical Systems (Cleveland) Inc
Brilliance iCT Computed Tomography X-ray system
Terminated
JAKK060937
Dec 24, 2015Philips Medical Systems (Cleveland) Inc
Brilliance 64 Computed Tomography X-ray system
Terminated
JAKK033326
Dec 10, 2015Philips Medical Systems (Cleveland) Inc
Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visu
Terminated
JAKK033357
Dec 10, 2015Philips Medical Systems (Cleveland) Inc
Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dat
Terminated
JAKK033326
Nov 2, 2015Philips Medical Systems (Cleveland) Inc
GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Terminated
JAKK032036
K051170 +1
Oct 23, 2015GE Medical Systems, LLC
GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cros
Terminated
JAKK133705
Oct 9, 2015Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-303A
Terminated
JAKK141741
Oct 9, 2015Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-302A
Terminated
JAKK120710
Oct 9, 2015Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-301C
Terminated
JAKK142465
Oct 9, 2015Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-301B
Terminated
JAKK120546
Oct 9, 2015Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-301A
Terminated
JAKK113466
Oct 9, 2015Toshiba American Medical Systems Inc
Toshiba Aquilion CT System TSX-101A
Terminated
JAKK080211
Oct 6, 2015Siemens Medical Solutions USA, Inc
SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.
Terminated
JAKK133589
Oct 5, 2015Siemens Medical Solutions USA, Inc
SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral
Terminated
JAKK143400
Oct 5, 2015Siemens Medical Solutions USA, Inc
SOMATOM Definition Flash; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spi
Terminated
JAKK143416
Oct 5, 2015Siemens Medical Solutions USA, Inc
SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spir
Terminated
JAKK143401
Sep 21, 2015GE Healthcare
Lightspeed 16 CT
Terminated
JAKK013561
K030420 +1
Sep 14, 2015Philips Medical Systems (Cleveland) Inc
Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Terminated
JAKK033326
Sep 14, 2015Philips Medical Systems (Cleveland) Inc
Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Terminated
JAKK033357
Sep 14, 2015Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Terminated
JAKK033326
Sep 14, 2015Philips Medical Systems (Cleveland) Inc
Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Terminated
JAKK033326
Sep 14, 2015Philips Medical Systems (Cleveland) Inc
Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Terminated
JAKK033326
Sep 14, 2015Philips Medical Systems (Cleveland) Inc
Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
Terminated
JAKK012009
Sep 6, 2015Philips Healthcare
Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
Terminated
JAKK033326
Sep 6, 2015Philips Healthcare
Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System
Terminated
JAKK033326
Sep 6, 2015Philips Healthcare
Philips Healthcare Ingenuity CT Computed Tomography X-Ray System
Terminated
JAKK033326
Sep 6, 2015Philips Healthcare
Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
Terminated
JAKK033326
Sep 6, 2015Philips Healthcare
Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
Terminated
JAKK060937
Sep 6, 2015Philips Healthcare
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
Terminated
JAKK060937
Sep 6, 2015Philips Healthcare
Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
Terminated
JAKK060937
Jul 24, 2015Philips Medical Systems (Cleveland) Inc
Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and pla
Terminated
JAKK033326
Jul 24, 2015Philips Medical Systems (Cleveland) Inc
Computed Tomography X-ray Systems Ingenuity Core 128. 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
Jul 24, 2015Philips Medical Systems (Cleveland) Inc
Computed Tomography X-ray Systems Ingenuity Core. 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

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