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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 Prioritization Software For Lesions
510(k) Number K202992
Device Name BriefCase, RIB Fractures Triage (RibFx)
Applicant
Aidoc Medical, Ltd.
3 Aminaday St.
Tel-Aviv,  IL 6706703
Applicant Contact Nimrod Epstein
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number892.2080
Classification Product Code
QFM  
Date Received09/30/2020
Decision Date 04/14/2021
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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