QFX — Diagnostic Neurosurgical Microscope Filter Class II
FDA product code QFX covers "Diagnostic Neurosurgical Microscope Filter", a Class II medical device regulated under 21 CFR 882.4950. Submissions are reviewed by the Neurology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QFX
- Device Class
- Class II
- Regulation Number
- 882.4950
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251286 | digital surgery systems, inc. (d.b.a true digital surgery) | Affirm 400 | January 21, 2026 |
| K240215 | carl zeiss meditec | BLUE 400; BLUE 400 S | June 28, 2024 |
| K232567 | nico corporation | Myriad SPECTRA Light Source | March 14, 2024 |
| K211346 | carl zeiss meditec | BLUE 400 | July 22, 2022 |
| DEN180024 | leica microsystems (schweiz) | Leica FL400 | March 28, 2019 |