510(k) K090403 ยท KPS System, Tomography, Computed, Emission
AUTOSPECT
| Applicant | Philips Medical Systems (Cleveland), Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Mar 31, 2009 |
| Received | Feb 17, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090403
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2016 | Philips Medical Systems (Cleveland) Inc Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH.
Provides software applica Terminated |
KPS | None listed |
| Mar 4, 2016 | Philips Medical Systems (Cleveland) Inc Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH.
Provides software Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.