510(k) K042880 ยท KPS System, Tomography, Computed, Emission
JETSTREAM WORKSPACE
| Applicant | Adac Laboratories, Milpitas CA, US |
| Decision | Substantially Equivalent, Nov 3, 2004 |
| Received | Oct 19, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042880
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2020 | Philips North America, LLC Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. Terminated |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.