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Product codes
QFX
Product code QFX
Device name
Diagnostic Neurosurgical Microscope Filter
Medical specialty
Neurology
Device class
2
Regulation number
882.4950
Review panel
NE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset
Related 510(k) Records
#
510(k), Device, Applicant table
510(k)
Device
Applicant
Decision date
K251286
Affirm 400
Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)
2026-01-21
K240215
BLUE 400; BLUE 400 S
Carl Zeiss Meditec, AG
2024-06-28
K232567
Myriad SPECTRA Light Source
Nico Corporation
2024-03-14
K211346
BLUE 400
Carl Zeiss Meditec, AG
2022-07-22
DEN180024
Leica FL400
Leica Microsystems (Schweiz) AG
2019-03-28
Related GUDID Devices
#
Primary DI, Brand, Company table
Primary DI
Brand
Company
Published
07630802403414
FL400 for M530
Leica Microsystems (Schweiz) AG
2025-10-09
04049539070159
BLUE 400
Carl Zeiss Meditec AG
2024-10-07
04049539070593
BLUE 400 S
Carl Zeiss Meditec AG
2024-10-07
00816744027728
NICO Myriad SPECTRA
NICO CORPORATION
2024-06-07
00816744027483
NICO Myriad SPECTRA
NICO CORPORATION
2024-04-01
00816744027537
NICO Myriad SPECTRA
NICO CORPORATION
2024-04-01