510(k) K170750 ยท MUJ System, Planning, Radiation Therapy Treatment
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
| Applicant | Brainlab AG, Munich, DE |
| Decision | Substantially Equivalent, Aug 24, 2017 |
| Received | Mar 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170750
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2019 | Brainlab AG RT Elements
Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected:
- Cranial SRS 1.0.0 Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.