510(k) K032063 ยท KPS System, Tomography, Computed, Emission
PEM 2400 PET SCANNER
| Applicant | Pem Technologies, Rockville MD, US |
| Decision | Substantially Equivalent, Aug 18, 2003 |
| Received | Jul 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032063
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2008 | Naviscan PET Systems Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology. Terminated |
KPS | None listed |
| Oct 11, 2007 | Naviscan PET Systems PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging. Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.