510(k) K082506 ยท KPS System, Tomography, Computed, Emission
SYMBIA, VERSION 4.0
| Applicant | Siemens Medical Solutions USA, Inc., Hoffman Estates IL, US |
| Decision | Substantially Equivalent, Nov 21, 2008 |
| Received | Aug 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082506
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2015 | Siemens Medical Solutions USA, Inc. The Siemens Symbia T series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. Terminated |
KPS | None listed |
| Jan 13, 2015 | Siemens Medical Solutions USA, Inc. Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies. Terminated |
KPS | None listed |
| Oct 22, 2014 | Siemens Medical Solutions USA, Inc. Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers.
It is used to detect or image the distribution of radionuclides in the body or organ. 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 |
| Aug 16, 2013 | Siemens Medical Solutions USA, Inc. Symbia T Series SPECT + CT
Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomo Terminated |
KPS | None listed |
| Nov 23, 2011 | Siemens Medical Solutions USA, Inc. Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography. Indications for use: SPECT + CT: Perform scans and nuclear imaging studies with the same Terminated |
KPS | None listed |
| Nov 23, 2011 | Siemens Medical Solutions USA, Inc. Siemens Medical Solutions USA, Inc., Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System. Terminated |
JAK | None listed |
| Aug 10, 2011 | Siemens Medical Solutions USA, Inc. Symbia Radiation Therapy Pallet.
Siemens Medical Solutions USA, Inc.
An accessory to the Symbia T Series Emission Computed Tomography System/X-Ray Computed Tomography System.This specialty pallet i Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.