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.
6
Total
5
Cleared
283d
Avg days
2019
Since
Stable submission activity - 2 submissions in the last 2 years
Consistent review times:
281d avg (recent)
FDA 510(k) Cleared Diagnostic Neurosurgical Microscope Filter Devices (Product Code QFX)
6 devices
Cleared
Oct 02, 2026
cCeLL405
VPIX Medical, Inc.
Neurology
290d
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
6 total 510(k) submissions under product code QFX since 2019, with 5 receiving FDA clearance (average review time: 283 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - QFX Product Code
FDA review times for QFX submissions have been consistent, averaging 281 days recently vs 284 days historically.
QFX devices are reviewed by the Neurology panel. Browse all Neurology devices →