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) |
|---|---|---|---|
| Feb 15, 2016 | Siemens 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 |
JAK | K013522 |
| Feb 15, 2016 | Siemens 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 |
JAK | K133424 |
| Feb 15, 2016 | Siemens 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 |
JAK | K050297 |
| Feb 15, 2016 | Siemens 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 |
JAK | K023687 |
| Feb 10, 2016 | GE 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 |
JAK | K030420 |
| Feb 10, 2016 | GE 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 |
JAK | K013561 |
| Feb 5, 2016 | Philips 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 |
JAK | K033326 |
| Feb 5, 2016 | Philips 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 |
JAK | K033326 |
| Feb 5, 2016 | Philips 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 |
JAK | K033326 |
| Feb 5, 2016 | Philips 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 |
JAK | K060937 |
| Feb 5, 2016 | Philips 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 |
JAK | K060937 |
| Feb 5, 2016 | Philips 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 |
JAK | K033326 |
| Jan 21, 2016 | Siemens 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 |
JAK | K142006 |
| Dec 24, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity CT Computed Tomography X-ray system Terminated |
JAK | K033326 |
| Dec 24, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128 Computed Tomography X-ray system Terminated |
JAK | K033326 |
| Dec 24, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity Core Computed Tomography X-ray system Terminated |
JAK | K033326 |
| Dec 24, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance iCT SP Computed Tomography X-ray system Terminated |
JAK | K060937 |
| Dec 24, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance iCT Computed Tomography X-ray system Terminated |
JAK | K060937 |
| Dec 24, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance 64 Computed Tomography X-ray system Terminated |
JAK | K033326 |
| Dec 10, 2015 | Philips 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 |
JAK | K033357 |
| Dec 10, 2015 | Philips 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 |
JAK | K033326 |
| Nov 2, 2015 | Philips 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 |
JAK | K032036 K051170 +1 |
| Oct 23, 2015 | GE 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 |
JAK | K133705 |
| Oct 9, 2015 | Toshiba American Medical Systems Inc Toshiba Aquilion CT System TSX-303A Terminated |
JAK | K141741 |
| Oct 9, 2015 | Toshiba American Medical Systems Inc Toshiba Aquilion CT System TSX-302A Terminated |
JAK | K120710 |
| Oct 9, 2015 | Toshiba American Medical Systems Inc Toshiba Aquilion CT System TSX-301C Terminated |
JAK | K142465 |
| Oct 9, 2015 | Toshiba American Medical Systems Inc Toshiba Aquilion CT System TSX-301B Terminated |
JAK | K120546 |
| Oct 9, 2015 | Toshiba American Medical Systems Inc Toshiba Aquilion CT System TSX-301A Terminated |
JAK | K113466 |
| Oct 9, 2015 | Toshiba American Medical Systems Inc Toshiba Aquilion CT System TSX-101A Terminated |
JAK | K080211 |
| Oct 6, 2015 | Siemens Medical Solutions USA, Inc SOMATOM Force; computed tomography x-ray system.
Intended to generate and process cross-sectional images of patients. Terminated |
JAK | K133589 |
| Oct 5, 2015 | Siemens 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 |
JAK | K143400 |
| Oct 5, 2015 | Siemens 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 |
JAK | K143416 |
| Oct 5, 2015 | Siemens 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 |
JAK | K143401 |
| Sep 21, 2015 | GE Healthcare Lightspeed 16 CT Terminated |
JAK | K013561 K030420 +1 |
| Sep 14, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Terminated |
JAK | K033326 |
| Sep 14, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Terminated |
JAK | K033357 |
| Sep 14, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Terminated |
JAK | K033326 |
| Sep 14, 2015 | Philips Medical Systems (Cleveland) Inc Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Terminated |
JAK | K033326 |
| Sep 14, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Terminated |
JAK | K033326 |
| Sep 14, 2015 | Philips Medical Systems (Cleveland) Inc Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body. Terminated |
JAK | K012009 |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System Terminated |
JAK | K033326 |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System Terminated |
JAK | K033326 |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Ingenuity CT Computed Tomography X-Ray System Terminated |
JAK | K033326 |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Ingenuity Core Computed Tomography X-Ray System Terminated |
JAK | K033326 |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System Terminated |
JAK | K060937 |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Brilliance iCT Computed Tomography X-Ray System Terminated |
JAK | K060937 |
| Sep 6, 2015 | Philips Healthcare Philips Healthcare Brilliance 64 Computed Tomography X-Ray System Terminated |
JAK | K060937 |
| Jul 24, 2015 | Philips 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 |
JAK | K033326 |
| Jul 24, 2015 | Philips 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 |
JAK | K033326 |
| Jul 24, 2015 | Philips 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 |
JAK | K033326 |
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