510(k) K081022 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM DEFINITION, MODEL AS/AS+
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jun 2, 2008 |
| Received | Apr 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081022
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 30, 2009 | Siemens Medical Solutions USA, Inc Somatom Definition Model AS/AS+, Model number 8098027.
Intended use: Computed Tomography X-ray system Terminated |
JAK | None listed |
| Jun 16, 2009 | Siemens Medical Solutions USA, Inc Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radiographic imaging systems. Component material number 10281152 3-bulb surgery lamp, 230V. Terminated |
JAK | None listed |
| Jan 23, 2009 | Siemens Medical Solutions USA, Inc Somatom Definition AS, Model number 8098027.
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.