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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 K252970
Device Name BriefCase-Triage: CARE Multi-triage CT Body
Applicant
Aidoc Medical , Ltd.
3 Aminadav St.
Tell-Aviv,  IL 6706703
Applicant Contact Amalia Schreier
Correspondent
Aidoc Medical , Ltd.
3 Aminadav St.
Tell-Aviv,  IL 6706703
Correspondent Contact Amalia Schreier
Regulation Number892.2080
Classification Product Code
QAS  
Subsequent Product Code
QFM  
Date Received09/17/2025
Decision Date 01/07/2026
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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