Radiological Computer-assisted Triage And Notification Software

Aidoc Medical, Ltd.

The following data is part of a premarket notification filed by Aidoc Medical, Ltd. with the FDA for Briefcase.

Pre-market Notification Details

Device IDK201020
510k NumberK201020
Device Name:BriefCase
ClassificationRadiological Computer-assisted Triage And Notification Software
Applicant Aidoc Medical, Ltd. 3 Aminadav St. Tel-aviv,  IL 6706703
ContactNimrod Epstein
CorrespondentJohn J. Smith
Hogan Lovells US LLP 555 Thirteenth Street, NW Washington,  DC  20004
Product CodeQAS  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-17
Decision Date2020-08-26

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