510(k) K040665 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM SENSATION 64 AND SENSATION CARDIAC
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Apr 2, 2004 |
| Received | Mar 4, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040665
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2016 | Siemens Medical Solutions USA, Inc Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either th Terminated |
JAK | None listed |
| Feb 15, 2016 | Siemens Medical Solutions USA, Inc Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either th Terminated |
JAK | None listed |
| Jan 5, 2009 | Siemens Medical Solutions USA, Inc Somatom Sensation 40 X-Ray System, Model number 8874427. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray Terminated |
JAK | None listed |
| Jan 5, 2009 | Siemens Medical Solutions USA, Inc Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray Terminated |
JAK | None listed |
| Apr 26, 2006 | Siemens Medical Solutions USA, Inc SOMATOM CT System Sensation 40 and Sensation 64. Computed tomography x-ray system. Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.