QFX

Diagnostic Neurosurgical Microscope Filter

Product code: QFX
Device name: Diagnostic Neurosurgical Microscope Filter
Device class: Class 2
21 CFR: 21 CFR 882.4950
Medical specialty: Neurology
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 5

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-01-21.

Number	Decision date	Applicant	Device name	Summary
K251286	2026-01-21	Digital Surgery Systems, Inc. (D.B.A T	Affirm 400	PDF
K240215	2024-06-28	Carl Zeiss Meditec, AG	BLUE 400; BLUE 400 S	PDF
K232567	2024-03-14	Nico Corporation	Myriad SPECTRA Light Source	PDF

3 summaries are archived here for direct download.

Official FDA classification page: QFX

Classification and pathway per current FDA publications. Data from openFDA (CC0).