510(k) K201632 ยท LLZ System, Image Processing, Radiological
TOMTEC-ARENA
| Applicant | Tomtec Imaging Systems GmbH, Unterschleissheim, DE |
| Decision | Substantially Equivalent, Aug 14, 2020 |
| Received | Jun 16, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201632
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.