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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Triage And Notification Software
510(k) Number K250685
Device Name Methinks NCCT Stroke
Applicant
Methinks Software, S.L
Pier 01, Plaça Pau Vila 1, Office 2d2
Barcelona,  ES 08039
Applicant Contact Claudia Carbonell
Correspondent
Methinks Software, S.L
Pier 01, Plaça Pau Vila 1, Office 2d2
Barcelona,  ES 08039
Correspondent Contact Claudia Carbonell
Regulation Number892.2080
Classification Product Code
QAS  
Date Received03/06/2025
Decision Date 06/16/2025
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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