510(k) K892875 ยท KPS System, Tomography, Computed, Emission
BIAD NUCLEAR IMAGING SYSTEM
| Applicant | Trionix Research Laboratory, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Jul 20, 1989 |
| Received | Apr 19, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892875
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2006 | Trionix Research Laboratory Inc BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System. Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.