QFX
5 FDA 510(k) clearances · Product code
271 daysmedian time to decision
445 days90th percentile
5clearances measured
FDA profile
- Official device name
- Diagnostic Neurosurgical Microscope Filter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4950
- Medical specialty
- Neurology
- FDA definition
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Affirm 400 (K251286) | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2026-01-21 |
| BLUE 400; BLUE 400 S (K240215) | Carl Zeiss Meditec, AG | 2024-06-28 |
| Myriad SPECTRA Light Source (K232567) | Nico Corporation | 2024-03-14 |
| BLUE 400 (K211346) | Carl Zeiss Meditec, AG | 2022-07-22 |
| Leica FL400 (DEN180024) | Leica Microsystems (Schweiz) AG | 2019-03-28 |
Track QFX automatically
Every clearance here is in the API, with alerts when new ones post.