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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 K230658
Device Name SKOUT® system
Applicant
Iterative Scopes Inc.
675 Massachusetts Ave
2nd Floor
Cambridge,  MA  02139
Applicant Contact Dennis Francoeur
Correspondent
Iterative Scopes Inc.
675 Massachusetts Ave
2nd Floor
Cambridge,  MA  02139
Correspondent Contact Dennis Francoeur
Regulation Number876.1520
Classification Product Code
QNP  
Date Received03/09/2023
Decision Date 04/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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