510(k) K132544 ยท LLZ System, Image Processing, Radiological
TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
| Applicant | Tomtec Imaging Systems GmbH, Unterschleissheim, DE |
| Decision | Substantially Equivalent, Nov 25, 2013 |
| Received | Aug 13, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132544
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.