510(k) K232759 · LLZ System, Image Processing, Radiological
Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
| Applicant | Brainlab AG, Münich, DE |
| Decision | Substantially Equivalent, May 21, 2024 |
| Received | Sep 8, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232759
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2025 | Brainlab AG Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.