510(k) K213544 ยท QIH Automated Radiological Image Processing Software
TOMTEC-ARENA
| Applicant | Tomtec Imaging Systems GmbH, Unterschleissheim, DE |
| Decision | Substantially Equivalent, Jan 6, 2022 |
| Received | Nov 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213544
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.