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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gastrointesinal lesion software detection system
510(k) Number K213686
Device Name SKOUT Software
Applicant
Iterative Scopes Inc.
14 Arrow St, 3rd Floor
Cambridge,  MA  02138
Applicant Contact Daniel Wang
Correspondent
Iterative Scopes Inc.
14 Arrow St, 3rd Floor
Cambridge,  MA  02138
Correspondent Contact Dennis Francoeur
Regulation Number876.1520
Classification Product Code
QNP  
Date Received11/22/2021
Decision Date 08/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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