K251286
- 510(k) number
- K251286
- Device name
- Affirm 400
- Applicant
- Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) CA · US
- Product code
- QFX — Diagnostic Neurosurgical Microscope Filter
- Decision date
- 2026-01-21
- Date received
- 2025-04-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251286.pdf
Official FDA record: K251286
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.