FDA product code QFX: Diagnostic Neurosurgical Microscope Filter
QFX is the FDA product code for diagnostic neurosurgical microscope filter. It is a Class II device, regulated under 21 CFR 882.4950 and reviewed by the Neurology panel. FDA has cleared 4 510(k) submissions under QFX, 4 in the last five years, from 3 different applicants. The average 510(k) review took 268 days (median 237); 224 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Diagnostic Neurosurgical Microscope Filter |
| Device class | Class II |
| Regulation | 21 CFR 882.4950 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for QFX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 445 |
| 2024 | 2 | 178 |
| 2026 | 1 | 271 |
Compare with all 510(k) review times · Search every QFX clearance
Top QFX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Carl Zeiss Meditec, AG | 2 | 2024-06-28 |
| Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 1 | 2026-01-21 |
| Nico Corporation | 1 | 2024-03-14 |
Most recent QFX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251286 | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | Affirm 400 | 2026-01-21 | 271 |
| K240215 | Carl Zeiss Meditec, AG | BLUE 400; BLUE 400 S | 2024-06-28 | 154 |
| K232567 | Nico Corporation | Myriad SPECTRA Light Source | 2024-03-14 | 203 |
| K211346 | Carl Zeiss Meditec, AG | BLUE 400 | 2022-07-22 | 445 |
Recalls for QFX devices
openFDA lists no recalls for product code QFX.
Frequently asked questions
What is FDA product code QFX?
QFX is the FDA product code for diagnostic neurosurgical microscope filter. It is a Class II device, regulated under 21 CFR 882.4950 and reviewed by the Neurology panel.
What device class is QFX?
Class II, regulation 21 CFR 882.4950. Typical premarket route: 510(k).
How long does a 510(k) take for product code QFX?
Across 4 cleared submissions the average was 268 days from receipt to decision (median 237).
Which companies have the most QFX clearances?
Carl Zeiss Meditec, AG (2); Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) (1); Nico Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QFX
- Run a recall and safety report across every QFX manufacturer
- Watch product code QFX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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