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U.S. Department of Health and Human Services

Product Classification
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Device diagnostic neurosurgical microscope filter
Regulation Description Diagnostic neurosurgical microscope filter.
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.
Physical State Microscope filter set that filters light
Technical Method Utilizes excitation and emission filters to be used with surgical operating microscopes to facilitate visualization of fluorescence within specific wavelength bands.
Target Area Neurosurgical targets including brain and spinal cord
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeQFX
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.4950
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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