510(k) K041166 ยท KPS System, Tomography, Computed, Emission
SIEMENS ENHANCED IMAGING SYSTEM
| Applicant | Siemens Medical Solutions USA, Inc., Hoffman Estates IL, US |
| Decision | Substantially Equivalent, May 17, 2004 |
| Received | May 4, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041166
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2015 | Siemens Medical Solutions USA, Inc. The Siemens Symbia S 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 |
| Aug 16, 2013 | Siemens Medical Solutions USA, Inc. Symbia S,
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, tomographic imaging fo Terminated |
KPS | None listed |
| Dec 29, 2009 | Siemens Medical Solutions USA, Inc. Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061.
Indications for use: SPECT + CT: Perform scans and nucle Terminated |
KPS | None listed |
| Dec 29, 2009 | Siemens Medical Solutions USA, Inc. Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061.
Indications for use: SPECT Terminated |
JAK | None listed |
| Aug 4, 2009 | Siemens Medical Solutions USA, Inc. Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061
Indications for use: SPECT + CT: Perform scans and nucle Terminated |
KPS | None listed |
| Aug 4, 2009 | Siemens Medical Solutions USA, Inc. Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; Siemens Medical Solutions USA, Inc., Hoffman Estates, IL 60195-2061
Indications for use: SPECT + Terminated |
KPS | None listed |
| Jul 7, 2009 | Siemens Medical Solutions USA, Inc. Siemens Medical Solutions USA, Inc., Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Part number 8717741. Terminated |
KPS | None listed |
| Jul 7, 2009 | 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 |
KPS | None listed |
| Oct 27, 2008 | Siemens Medical Solutions USA, Inc. Symbia T6 System; a dual-detector variable angle gamma camera with a six slice CT scanner; Siemens Medical Solutions USA, Inc., Molecular imaging, Hoffman Estates, IL 60192. The system is used to per Terminated |
KPS | None listed |
| Oct 27, 2008 | Siemens Medical Solutions USA, Inc. Symbia T16 System; a dual-detector variable angle gamma camera with a sixteen slice CT scanner; Siemens Medical Solutions USA, Inc., Molecular imaging, Hoffman Estates, IL 60192. The system is used t Terminated |
KPS | None listed |
| Feb 23, 2007 | Siemens Medical Solutions USA, Inc. Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, I Terminated |
KPS | None listed |
| Feb 23, 2007 | Siemens Medical Solutions USA, Inc. Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barringt Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.