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, Nico Corporation and Digital Surgery Systems, Inc. (D.B.A True Digital Surgery).
FDA 510(k) Cleared Diagnostic Neurosurgical Microscope Filter Devices (Product Code QFX)
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 remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
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 →