510(k) K140651 ยท KPS System, Tomography, Computed, Emission
CELESTEION, PCA-9000A/2
| Applicant | Toshibamedical Systems Corporation, Tustin CA, US |
| Decision | Substantially Equivalent, Jun 11, 2014 |
| Received | Mar 13, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140651
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2016 | Toshiba American Medical Systems Inc Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B
This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). Th Terminated |
KPS | None listed |
| Oct 7, 2015 | Toshiba American Medical Systems Inc Celesteion PCA-9000A/2 PET/CT System Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.