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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)
Jul 20, 2016Philips Medical Systems (Cleveland) Inc
Brilliance BigBore Radiology CT Model number 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmi
Terminated
JAKK033357
Jul 20, 2016Philips Medical Systems (Cleveland) Inc
Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transm
Terminated
JAKK033357
Jul 20, 2016Philips Medical Systems (Cleveland) Inc
Brilliance 64 CT Model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data take
Terminated
JAKK033326
Jun 21, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.
Terminated
JAKK033326
Jun 21, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.
Terminated
JAKK033326
Jun 21, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.
Terminated
JAKK033326
Jun 21, 2016Philips Medical Systems (Cleveland) Inc
Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.
Terminated
JAKK060937
Jun 21, 2016Philips Medical Systems (Cleveland) Inc
Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.
Terminated
JAKK033357
Jun 14, 2016Philips Medical Systems (Cleveland) Inc
Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of
Terminated
JAKK033357
Jun 14, 2016Philips Medical Systems (Cleveland) Inc
Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of th
Terminated
JAKK033357
May 24, 2016Northridge Tri-Modality Imaging,
TriFoillmaging Triumph/Triumph II Research CT scanners.
Terminated
JAKNone listed
May 9, 2016GE Healthcare, LLC
GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by comp
Terminated
JAKK133705
Apr 29, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity CT Model No. 728326; To produce cross-sectional images of the body.
Terminated
JAKK033326
Apr 29, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body.
Terminated
JAKK033326
Apr 29, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core Model No. 728321; To produce cross-sectional images of the body.
Terminated
JAKK033326
Apr 29, 2016Philips Medical Systems (Cleveland) Inc
Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body.
Terminated
JAKK060937
Apr 29, 2016Philips Medical Systems (Cleveland) Inc
Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.
Terminated
JAKK060937
Apr 29, 2016Philips Medical Systems (Cleveland) Inc
Brilliance 64 CT Model 728231; To produce cross-sectional images of the body.
Terminated
JAKK033326
Apr 29, 2016GE Medical Systems, LLC
GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
Terminated
JAKK133705
Apr 27, 2016Philips and Neusoft Medical Systems Co., Ltd.
NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to
Terminated
JAKK090173
K092742
Apr 22, 2016Siemens Medical Solutions USA, Inc
SOMATOM Force, Computed Tomography x-ray system intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
Terminated
JAKK133589
Apr 20, 2016Philips Medical Systems (Cleveland) Inc
MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool.
Terminated
JAKK091195
Apr 20, 2016Philips Medical Systems (Cleveland) Inc
MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool.
Terminated
JAKK091195
Apr 19, 2016Siemens Medical Solutions USA, Inc
Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
Terminated
JAKK120579
Apr 19, 2016Siemens Medical Solutions USA, Inc
Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
Terminated
JAKK121072
Apr 19, 2016Siemens Medical Solutions USA, Inc
Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
Terminated
JAKK143400
Apr 19, 2016Siemens Medical Solutions USA, Inc
Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system.
Terminated
JAKK122471
Apr 12, 2016Toshiba American Medical Systems Inc
Aquilion Lightning CT System iStation cover, SID: 70000246, Item Code: TSX-0354A/2D.03 Product Usage: Aquilion Lightning is a multislice helical CT system that supports whole-body imaging. The system
Terminated
JAKK151833
Apr 8, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and p
Terminated
JAKK033326
Apr 8, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different ang
Terminated
JAKK033326
Apr 8, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angl
Terminated
JAKK033326
Apr 8, 2016Philips Medical Systems (Cleveland) Inc
Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles a
Terminated
JAKK033326
Apr 8, 2016Siemens Medical Solutions USA, Inc
SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at diff
Terminated
JAKK143400
Apr 1, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the bo
Terminated
JAKK033326
Apr 1, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by co
Terminated
JAKK033326
Apr 1, 2016Philips Medical Systems (Cleveland) Inc
Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by
Terminated
JAKK033326
Mar 24, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and plane
Terminated
JAKK033326
Mar 24, 2016Philips Medical Systems (Cleveland) Inc
Ingenuity Core Computed Tomography X-ray systems is 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
Mar 24, 2016Philips Medical Systems (Cleveland) Inc
Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and p
Terminated
JAKK012009
Mar 24, 2016Philips Medical Systems (Cleveland) Inc
Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Terminated
JAKK012009
Mar 24, 2016Philips Medical Systems (Cleveland) Inc
Brilliance BigBore Radiology 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 a
Terminated
JAKK033357
Mar 24, 2016Philips Medical Systems (Cleveland) Inc
Brilliance BigBore Oncology 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 an
Terminated
JAKK033357
Mar 24, 2016Philips Medical Systems (Cleveland) Inc
Brilliance 64 Computed Tomography X-ray systems is 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
Mar 15, 2016Philips Electronics North America Corporation
Philips Healthcare System X-ray Tomography Computed :
Terminated
JAKNone listed
Mar 15, 2016Philips Electronics North America Corporation
Philips Healthcare System X-ray Tomography Computed :
Terminated
JAKNone listed
Mar 4, 2016Philips Medical Systems (Cleveland) Inc
IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data.
Terminated
JAKK012009
K033326 +1
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
JAKK040577
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
JAKK040665
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
JAKK040665
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

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