510(k) K200546 ยท LLZ System, Image Processing, Radiological
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| Applicant | O3 Enterprise Srl, Tieste, IT |
| Decision | Substantially Equivalent, May 5, 2020 |
| Received | Mar 3, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200546
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.