CINA CHEST

Radiological Computer-assisted Triage And Notification Software

Avicenna.AI

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

Pre-market Notification Details

Device IDK210237
510k NumberK210237
Device Name:CINA CHEST
ClassificationRadiological Computer-assisted Triage And Notification Software
Applicant Avicenna.AI 93 Avenue Du Sorbiers, Zone Athelia IV La Ciotat,  FR 13600
ContactStephane Berger
CorrespondentJohn J. Smith
Hogan Lovells US LLP 555 13th St. NW Washington,  DC  20004
Product CodeQAS  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-28
Decision Date2021-05-19

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B826CINACHEST100 K210237 000

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