510(k) clearance
cCeLL405
- 510(k) number
- K254030
- Applicant
- VPIX Medical, Inc.
- Decision date
- Oct 2, 2026
- Date received
- Dec 16, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QFX
- Device type
- Diagnostic Neurosurgical Microscope Filter
- Device class
- Class II
- Regulation
- 21 CFR 882.4950
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Daejeon, KR