510(k) K243633 ยท QIH Automated Radiological Image Processing Software
Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)
| Applicant | Brainlab AG, Munich, DE |
| Decision | Substantially Equivalent, Jun 13, 2025 |
| Received | Nov 25, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243633
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.