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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 K192051
Device Name THINQ
CorticoMetrics LLC
128 Granite St.
Rockport,  MA  01966
Applicant Contact Nick Schmansky
CorticoMetrics LLC
128 Granite St.
Rockport,  MA  01966
Correspondent Contact Nick Schmansky
Regulation Number892.2050
Classification Product Code
Date Received07/31/2019
Decision Date 09/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No