510(k) K251286
K251286 is an FDA 510(k) premarket notification submitted by Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) for the device "Affirm 400". The FDA issued a decision of Substantially Equivalent on January 21, 2026. The device falls under product code QFX (Diagnostic Neurosurgical Microscope Filter), a Class II device regulated under 21 CFR 882.4950. Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2026
- Date Received
- April 25, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diagnostic Neurosurgical Microscope Filter
- Device Class
- Class II
- Regulation Number
- 882.4950
- Review Panel
- NE
- Submission Type
A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition.