DeviceClearance

Product code QFX— Neurology

Affirm 400

Classification name
Diagnostic Neurosurgical Microscope Filter
Device class
Class 2
Regulation
21 CFR 882.4950
Advisory panel
Neurology
Total cleared
5
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QFX under 21 CFR 882.4950, via openFDA

Market context for product code QFX

FDA has cleared 5 devices under product code QFX between 2019 and 2026, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QFX

Recent clearances under product code QFX

Data sourced from openFDA. This site is unofficial and independent of the FDA.