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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 K221314
Device Name BriefCase
Applicant
Aidoc Medical, Ltd.
3 Aminadav St.
Tel Aviv,  IL 6706703
Applicant Contact Nimrod Epstein
Correspondent
Hogan Lovells US LLP
555 Thirteenth St.
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number892.2080
Classification Product Code
QAS  
Date Received05/05/2022
Decision Date 06/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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