510(k) K251286 ยท QFX Diagnostic Neurosurgical Microscope Filter
Affirm 400
| Applicant | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery), Goleta CA, US |
| Decision | Substantially Equivalent, Jan 21, 2026 |
| Received | Apr 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251286
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.