510(k) K080961 ยท LLZ System, Image Processing, Radiological
NM APPLICATION SUITE
| Applicant | Philips Nuclear Medicine, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, Apr 18, 2008 |
| Received | Apr 4, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080961
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2011 | Philips Medical Systems Extended Brilliance Workstation-NM (EBW-NM)
with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test Period
A nuclear medicine image display and processing application suite that provi Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.