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510(k) Data Aggregation
K Number
K250686Device Name
GyriCalc (Version 1.0.0)
Manufacturer
NeuroSpectrum Insights Corp.
Date Cleared
2025-07-22
(138 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
NeuroSpectrum Insights Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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