Diagnostic Neurosurgical Microscope Filter
The 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, functioning as a specialized optical filter on a surgical microscope. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 882.4950 in the Neurology specialty. The product code is QFX. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QFX
- Device Class
- FDA class 2
- Regulation Number
- 882.4950
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251286 | Affirm 400 | Jan 21, 2026 | Substantially Equivalent | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) |
| K240215 | BLUE 400; BLUE 400 S | Jun 28, 2024 | Substantially Equivalent | Carl Zeiss Meditec, AG |
| K232567 | Myriad SPECTRA Light Source | Mar 14, 2024 | Substantially Equivalent | Nico Corporation |
| K211346 | BLUE 400 | Jul 22, 2022 | Substantially Equivalent | Carl Zeiss Meditec, AG |
| DEN180024 | Leica FL400 | Mar 28, 2019 | Unknown | Leica Microsystems (Schweiz) AG |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.