510(k) K142006 ยท KPS System, Tomography, Computed, Emission
SYMBIA 6.0
| Applicant | Siemens Medical Solutions USA, Inc., Hoffman Estates IL, US |
| Decision | Substantially Equivalent, Aug 21, 2014 |
| Received | Jul 23, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142006
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2016 | Siemens Medical Solutions USA, Inc. e.cam and Symbia E gamma camera systems with patient beds
To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging Terminated |
IYX | None listed |
| Mar 31, 2016 | Siemens Medical Solutions USA, Inc. E.cam or Symbia systems that use foresight detectors - Product Usage: 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 |
| Feb 26, 2016 | Siemens Medical Solutions USA, Inc. The E.CAM gamma camera system
Product Usage:
The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various me Terminated |
KPS | None listed |
| Feb 26, 2016 | Siemens Medical Solutions USA, Inc. The Symbia gamma camera system
Product Usage:
The Symbia gamma camera system is a computed tomography x-ray system which is a diagnostic x-ray system intended to produce cross-sectional images of th Terminated |
KPS | None listed |
| Jan 21, 2016 | Siemens Medical Solutions USA, Inc. The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomog Terminated |
JAK | None listed |
| Nov 4, 2015 | Siemens Medical Solutions USA, Inc. e.cam Gamma Camera, an emission computed tomography system. It is intended to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, wh Terminated |
KPS | None listed |
| Aug 20, 2015 | Siemens Medical Solutions USA, Inc. Siemens Symbia S Series system, a diagnostic analog or digital detector based planar (2- dimensional) nuclear medicine (NM) imaging system installed and used in only one location within an imaging fac Terminated |
KPS | None listed |
| Aug 20, 2015 | Siemens Medical Solutions USA, Inc. Siemens Symbia T Series, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomograph Terminated |
KPS | None listed |
| Aug 20, 2015 | Siemens Medical Solutions USA, Inc. Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomo Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.