510(k) K973148 ยท LLZ System, Image Processing, Radiological
MACOM
| Applicant | A.Stein - Regulatory Affairs Consulting, Ginot Shomron 44853, IL |
| Decision | Substantially Equivalent, Nov 20, 1997 |
| Received | Aug 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973148
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.