Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

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)
3
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
5 (all years; only the last 3 years are listed here)

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.

NumberDecision dateApplicantDevice nameSummary
K2512862026-01-21Digital Surgery Systems, Inc. (D.B.A T…Affirm 400PDF
K2402152024-06-28Carl Zeiss Meditec, AGBLUE 400; BLUE 400 SPDF
K2325672024-03-14Nico CorporationMyriad SPECTRA Light SourcePDF

3 summaries are archived here for direct download.

Official FDA classification page: QFX
Classification and pathway per current FDA publications. Data from openFDA (CC0).