BriefCase, RIB Fractures Triage (RibFx)

Radiological Computer-assisted Prioritization Software For Lesions

Aidoc Medical, Ltd.

The following data is part of a premarket notification filed by Aidoc Medical, Ltd. with the FDA for Briefcase, Rib Fractures Triage (ribfx).

Pre-market Notification Details

Device IDK202992
510k NumberK202992
Device Name:BriefCase, RIB Fractures Triage (RibFx)
ClassificationRadiological Computer-assisted Prioritization Software For Lesions
Applicant Aidoc Medical, Ltd. 3 Aminaday St. Tel-aviv,  IL 6706703
ContactNimrod Epstein
CorrespondentJohn J. Smith
Hogan Lovells US LLP 555 Thirteenth Street NW Washington,  DC  20004
Product CodeQFM  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-30
Decision Date2021-04-14

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