FDA Product Code QFX: Diagnostic Neurosurgical Microscope Filter
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.
Leading manufacturers include Carl Zeiss Meditec, AG, Leica Microsystems (Schweiz) AG and Nico Corporation.
5
Total
4
Cleared
282d
Avg days
2019
Since
Declining activity -
2 submissions in the last 2 years
vs 3 in the prior period
Review times improving: avg
213d
recently vs 328d historically
FDA 510(k) Cleared Diagnostic Neurosurgical Microscope Filter Devices (Product Code QFX)
5 devices
Cleared
Jan 21, 2026
Affirm 400
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
Neurology
271d
Cleared
Jun 28, 2024
BLUE 400
Carl Zeiss Meditec, AG
Neurology
154d
Cleared
Mar 14, 2024
Myriad SPECTRA Light Source
Nico Corporation
Neurology
203d
Cleared
Jul 22, 2022
BLUE 400
Carl Zeiss Meditec, AG
Neurology
445d
Not Cleared
Mar 28, 2019
Leica FL400
Leica Microsystems (Schweiz) AG
Neurology
335d
About Product Code QFX - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code QFX since 2019, with 4 receiving FDA clearance (average review time: 282 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 3 in the prior period.
FDA 510(k) Review Time - QFX Product Code
Recent submissions under QFX have taken an average of 213 days to reach a decision - down from 328 days historically, suggesting improved FDA processing for this classification.
QFX devices are reviewed by the Neurology panel. Browse all Neurology devices →