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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Capsule Endoscopy Analysis Software Device
510(k) Number K250655
Device Name Deep Capsule® (Deep Capsule US)
Applicant
Digestaid - Artificial Intelligence Development SA
Rua Particular Carlos Fontes, 117, São Cosme
Gondomar,  PT 4420-249
Applicant Contact Miguel Mascarenhas
Correspondent
Digestaid - Artificial Intelligence Development SA
Rua Particular Carlos Fontes, 117, São Cosme
Gondomar,  PT 4420-249
Correspondent Contact Miguel Mascarenhas
Classification Product Code
QZF  
Date Received03/05/2025
Decision Date 03/12/2026
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
Predetermined Change
Control Plan Authorized		 No
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