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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K250686
Device Name GyriCalc (Version 1.0.0)
Applicant
Neurospectrum Insights Corp.
376 Main St. Suite 100
Bedminster,  NJ  07921
Applicant Contact Andrew Stewart
Correspondent
Innolitics, LLC
1101 W 34th St.
Suite 550
Austin,  TX  78705
Correspondent Contact James Luker
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/06/2025
Decision Date 07/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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