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) |
|---|---|---|---|
| Jul 20, 2016 | Philips 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 |
JAK | K033357 |
| Jul 20, 2016 | Philips 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 |
JAK | K033357 |
| Jul 20, 2016 | Philips 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 |
JAK | K033326 |
| Jun 21, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body. Terminated |
JAK | K033326 |
| Jun 21, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body. Terminated |
JAK | K033326 |
| Jun 21, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body. Terminated |
JAK | K033326 |
| Jun 21, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance iCT model #728306; Intended to produce cross- sectional images of the body. Terminated |
JAK | K060937 |
| Jun 21, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body. Terminated |
JAK | K033357 |
| Jun 14, 2016 | Philips 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 |
JAK | K033357 |
| Jun 14, 2016 | Philips 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 |
JAK | K033357 |
| May 24, 2016 | Northridge Tri-Modality Imaging, TriFoillmaging Triumph/Triumph II Research CT scanners. Terminated |
JAK | None listed |
| May 9, 2016 | GE 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 |
JAK | K133705 |
| Apr 29, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity CT Model No. 728326; To produce cross-sectional images of the body. Terminated |
JAK | K033326 |
| Apr 29, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body. Terminated |
JAK | K033326 |
| Apr 29, 2016 | Philips Medical Systems (Cleveland) Inc Ingenuity Core Model No. 728321; To produce cross-sectional images of the body. Terminated |
JAK | K033326 |
| Apr 29, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the body. Terminated |
JAK | K060937 |
| Apr 29, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body. Terminated |
JAK | K060937 |
| Apr 29, 2016 | Philips Medical Systems (Cleveland) Inc Brilliance 64 CT Model 728231; To produce cross-sectional images of the body. Terminated |
JAK | K033326 |
| Apr 29, 2016 | GE Medical Systems, LLC GE, Revolution CT.
The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications Terminated |
JAK | K133705 |
| Apr 27, 2016 | Philips 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 |
JAK | K090173 K092742 |
| Apr 22, 2016 | Siemens 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 |
JAK | K133589 |
| Apr 20, 2016 | Philips Medical Systems (Cleveland) Inc MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnostic tool. Terminated |
JAK | K091195 |
| Apr 20, 2016 | Philips Medical Systems (Cleveland) Inc MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic tool. Terminated |
JAK | K091195 |
| Apr 19, 2016 | Siemens 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 |
JAK | K120579 |
| Apr 19, 2016 | Siemens Medical Solutions USA, Inc Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system. Terminated |
JAK | K121072 |
| Apr 19, 2016 | Siemens Medical Solutions USA, Inc Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system. Terminated |
JAK | K143400 |
| Apr 19, 2016 | Siemens Medical Solutions USA, Inc Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system. Terminated |
JAK | K122471 |
| Apr 12, 2016 | Toshiba 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 |
JAK | K151833 |
| Apr 8, 2016 | Philips 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 |
JAK | K033326 |
| Apr 8, 2016 | Philips 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 |
JAK | K033326 |
| Apr 8, 2016 | Philips 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 |
JAK | K033326 |
| Apr 8, 2016 | Philips 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 |
JAK | K033326 |
| Apr 8, 2016 | Siemens 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 |
JAK | K143400 |
| Apr 1, 2016 | Philips 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 |
JAK | K033326 |
| Apr 1, 2016 | Philips 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 |
JAK | K033326 |
| Apr 1, 2016 | Philips 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 |
JAK | K033326 |
| Mar 24, 2016 | Philips 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 |
JAK | K033326 |
| Mar 24, 2016 | Philips 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 |
JAK | K033326 |
| Mar 24, 2016 | Philips 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 |
JAK | K012009 |
| Mar 24, 2016 | Philips 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 |
JAK | K012009 |
| Mar 24, 2016 | Philips 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 |
JAK | K033357 |
| Mar 24, 2016 | Philips 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 |
JAK | K033357 |
| Mar 24, 2016 | Philips 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 |
JAK | K033326 |
| Mar 15, 2016 | Philips Electronics North America Corporation Philips Healthcare System X-ray Tomography Computed : Terminated |
JAK | None listed |
| Mar 15, 2016 | Philips Electronics North America Corporation Philips Healthcare System X-ray Tomography Computed : Terminated |
JAK | None listed |
| Mar 4, 2016 | Philips 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 |
JAK | K012009 K033326 +1 |
| 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 | K040577 |
| 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 | K040665 |
| 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 | K040665 |
| 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 |
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