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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
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