510(k) K212420 ยท LLZ System, Image Processing, Radiological
Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio
| Applicant | Brainlab AG, Munich, DE |
| Decision | Substantially Equivalent, Dec 16, 2021 |
| Received | Aug 4, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212420
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.