510(k) K982911 ยท KPS System, Tomography, Computed, Emission
FORTE
| Applicant | Adac Laboratories, Milpitas CA, US |
| Decision | Substantially Equivalent, Nov 16, 1998 |
| Received | Aug 18, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982911
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2019 | Philips Medical Systems (Cleveland) Inc Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personn Terminated |
KPS | None listed |
| Nov 1, 2019 | Philips Medical Systems (Cleveland) Inc Forte Gamma Camera System is intended to produce images depicting the anatomical distribution of single-photon and positron-emitting radioisotopes within the body for interpretation by medical personn Terminated |
KPS | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.