Radiological Computer-assisted Triage And Notification Software


The following data is part of a premarket notification filed by with the FDA for Cina.

Pre-market Notification Details

Device IDK200855
510k NumberK200855
Device Name:CINA
ClassificationRadiological Computer-assisted Triage And Notification Software
Applicant AVICENNA.AI 93 Avenue Des Sorbiers, Zone Athelia IV La Ciotat,  FR 13600
ContactCyril Di Grandi
CorrespondentJohn J. Smith
Hogan Lovells US LLP 555 13th St. NW Washington,  DC  20004
Product CodeQAS  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-31
Decision Date2020-06-24

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