510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QFXClass II

Diagnostic Neurosurgical Microscope Filter

21 CFR 882.4950 / Neurology
FDA source (opens on fda.gov)

QFX is the FDA product code for Diagnostic Neurosurgical Microscope Filter, a class II device type, regulated under 21 CFR 882.4950. FDA's definition for this code reads: "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". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QFX
Device name
Diagnostic Neurosurgical Microscope Filter
FDA 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.
Regulation
21 CFR 882.4950
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code QFX

By decision year
5 clearances under product code QFX with a decision year between 2019 and 2026, 2024 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QFX by decision year
YearClearances
20191
20221
20242
20261

Applicants with the most clearances

Product code QFX
Applicants holding the most 510(k) clearances under product code QFX
ApplicantClearances
Carl Zeiss Meditec Inc2
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)1
Leica Microsystems (Schweiz) AG1
Nico Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code