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)
Top companies in JAK
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2017 | Philips 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 |
JAK | None listed |
| Jan 18, 2017 | Philips 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 |
JAK | None listed |
| Jan 18, 2017 | Philips 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 |
JAK | None listed |
| Dec 23, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance iCT Terminated |
JAK | K060937 |
| Dec 16, 2016 | Philips 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 |
JAK | K133674 |
| Dec 2, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Force, System x-ray, tomography, computed Terminated |
JAK | K133589 |
| Nov 25, 2016 | Philips 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 |
JAK | K060937 |
| Nov 22, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Perspective, Computed tomography x-ray system Terminated |
JAK | K151765 |
| Nov 22, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Scope Power, Computed tomography x-ray system Terminated |
JAK | K151749 |
| Nov 22, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Scope, Computed tomography x-ray system Terminated |
JAK | K151749 |
| Nov 18, 2016 | Toshiba 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 |
JAK | K141741 |
| Nov 17, 2016 | Siemens 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 |
JAK | K121072 |
| Nov 17, 2016 | Siemens 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 |
JAK | K143400 |
| Nov 15, 2016 | Siemens 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 |
JAK | K152036 |
| Nov 15, 2016 | Siemens 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 |
JAK | K143416 |
| Nov 15, 2016 | Siemens 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 |
JAK | K152036 |
| Nov 14, 2016 | Philips 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 |
JAK | K150665 |
| Nov 14, 2016 | Philips 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 |
JAK | K133674 |
| Nov 12, 2016 | Philips 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 |
JAK | K160743 |
| Nov 12, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128 728323 Terminated |
JAK | K160743 |
| Nov 12, 2016 | Philips 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 |
JAK | K160743 |
| Nov 12, 2016 | Philips 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 |
JAK | K033326 |
| Nov 12, 2016 | Philips 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 |
JAK | K033326 |
| Nov 8, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition Flash
system, x-ray, tomography, computed Terminated |
JAK | K143416 |
| Nov 8, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS
system, x-ray, tomography, computed Terminated |
JAK | K143409 |
| Nov 2, 2016 | Siemens 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 |
JAK | K143416 |
| Nov 2, 2016 | Siemens 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 |
JAK | K152036 |
| Nov 2, 2016 | Siemens 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 |
JAK | K152036 |
| Oct 13, 2016 | Philips Medical Systems (Cleveland) Inc IQon Spectral CT Computed Tomography X-ray system, Model 728332 Terminated |
JAK | K133674 |
| Oct 13, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core Computed Tomography X-ray system, Model 728321 Terminated |
JAK | K160743 |
| Oct 13, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128 Computed Tomography X-ray system, Model 728323 Terminated |
JAK | K160743 |
| Oct 13, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity CT Computed Tomography X-ray system, Model 728326 Terminated |
JAK | K160743 |
| Oct 13, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance ICT SP Computed Tomography X-ray system, Model 728311 Terminated |
JAK | K060937 |
| Oct 13, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance iCT Computed Tomography X-ray system, Model 728306 Terminated |
JAK | K060937 |
| Oct 6, 2016 | Toshiba American Medical Systems Inc Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner Terminated |
JAK | None listed |
| Oct 6, 2016 | Toshiba 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 |
JAK | None listed |
| Oct 6, 2016 | Toshiba American Medical Systems Inc Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner. Terminated |
JAK | None listed |
| Aug 31, 2016 | Neusoft Medical Systems Co., Ltd. NeuViz 128 Multi-slice CT Scanner System with
software version 1.0.7.4038+P06 or previous version Terminated |
JAK | K121792 |
| Aug 31, 2016 | Neusoft Medical Systems Co., Ltd. NeuViz 64 Multi-slice CT Scanner Systems Terminated |
JAK | K121792 |
| Aug 24, 2016 | Philips 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 |
JAK | K033326 |
| Aug 24, 2016 | Philips 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 |
JAK | K033326 |
| Aug 24, 2016 | Philips 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 |
JAK | K033326 |
| Aug 24, 2016 | Philips 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 |
JAK | K033326 |
| Aug 23, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 computed tomography x-ray system Terminated |
JAK | K143401 |
| Aug 23, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, computed tomography x-ray system Terminated |
JAK | K143416 |
| Aug 23, 2016 | Siemens Medical Solutions USA, Inc SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, computed tomography x-ray system Terminated |
JAK | K143409 |
| Jul 20, 2016 | Philips 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 |
JAK | K033326 |
| Jul 20, 2016 | Philips 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 |
JAK | K033326 |
| Jul 20, 2016 | Philips 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 |
JAK | K012009 |
| Jul 20, 2016 | Philips 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 |
JAK | K012009 |
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