510(k) K042328 ยท JAK System, X-Ray, Tomography, Computed
SOMATOM SPIRIT
| Applicant | Siemens Medical Systems, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Sep 14, 2004 |
| Received | Aug 27, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042328
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2018 | Siemens Medical Solutions USA, Inc SOMATOM Spirit
Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data. Terminated |
JAK | None listed |
| Jun 4, 2014 | Siemens Medical Solutions USA, Inc Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography Systems
Product Usage: To produce cross-sectional images of the body by computer reconstruction of x-ray transmission d Terminated |
JAK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.