510(k) K131634 ยท KPS System, Tomography, Computed, Emission
SYMBIA
| Applicant | Siemens Medical Solutions USA, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Aug 16, 2013 |
| Received | Jun 4, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131634
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2015 | Siemens Medical Solutions USA, Inc. The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and or Terminated |
KPS | None listed |
| Jan 6, 2015 | Siemens Medical Solutions USA, Inc. The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and or Terminated |
KPS | None listed |
| Jan 6, 2015 | Siemens Medical Solutions USA, Inc. The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support for only attenuation correction and anatomical localization.
The Symbia Intevo Series are xSPECT systems. These are SPECT Terminated |
KPS | None listed |
| Sep 29, 2014 | Siemens Medical Solutions USA, Inc. The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The Terminated |
KPS | None listed |
| Sep 29, 2014 | Siemens Medical Solutions USA, Inc. The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quali Terminated |
KPS | None listed |
| Jul 11, 2014 | Siemens Medical Solutions USA, Inc. e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body ima Terminated |
KPS | None listed |
| Jul 11, 2014 | Siemens Medical Solutions USA, Inc. Symbia E camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.