510(k) K162337 ยท KPS System, Tomography, Computed, Emission
Symbia 6.5
| Applicant | Siemens Medical Solutions USA, Inc., Hoffman Estates IL, US |
| Decision | Substantially Equivalent, Sep 8, 2016 |
| Received | Aug 22, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162337
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2018 | Siemens Medical Solutions USA, Inc. EVO Excel, Emission Computed Tomographic System, Material Number 10910501 Terminated |
KPS | None listed |
| Nov 7, 2017 | Siemens Medical Solutions USA, Inc. Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System
To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole Terminated |
KPS | None listed |
| Nov 7, 2017 | Siemens Medical Solutions USA, Inc. Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System
To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole b Terminated |
KPS | None listed |
| Sep 18, 2017 | Siemens Medical Solutions USA, Inc. Torque wrench used on the bolts for the Symbia T2 model 10275008, Symbia Intevo Excel model 10764801, Symbia Intevo 16 model 10764804, Symbia Evo model 10910500, and Symbia Evo Excel model 10910501 de Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.