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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 K261317
Device Name BriefCase-Triage
Applicant
Aidoc Medical , Ltd.
34 Hamasger St.
Tel Aviv,  IL 6721119
Applicant Contact Amalia Schreier
Correspondent
Aidoc Medical , Ltd.
34 Hamasger St.
Tel Aviv,  IL 6721119
Correspondent Contact Amalia Schreier
Regulation Number892.2080
Classification Product Code
QAS  
Date Received04/21/2026
Decision Date 05/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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