Diagnostic Neurosurgical Microscope Filter
FDA product code QFX · Class II (moderate risk) · 21 CFR 882.4950 · Neurology
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.
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251286 | Affirm 400QFX · Traditional | Digital Surgery Systems, Inc. (D.B.A True… | 01/21/2026SE |
| K240215 | Blue 400; Blue 400 SQFX · Traditional | Carl Zeiss Meditec, AG | 06/28/2024SE |
| K232567 | Myriad SPECTRA Light SourceQFX · Traditional | Nico Corporation | 03/14/2024SE |
| K211346 | Blue 400QFX · Traditional | Carl Zeiss Meditec, AG | 07/22/2022SE |