DrAid For Radiology V1

Radiological Computer-assisted Prioritization Software For Lesions

VinBrain Joint Stock Company

The following data is part of a premarket notification filed by Vinbrain Joint Stock Company with the FDA for Draid For Radiology V1.

Pre-market Notification Details

Device IDK221241
510k NumberK221241
Device Name:DrAid For Radiology V1
ClassificationRadiological Computer-assisted Prioritization Software For Lesions
Applicant VinBrain Joint Stock Company No 7 Bang Lang 1 Street, Vinhomes Riverside Ecological Urban Area Viet Hung Ward, Long Bien District,  VN
ContactNguyen Nhat Linh
CorrespondentNguyen Nhat Linh
VinBrain Joint Stock Company No 7 Bang Lang 1 Street, Vinhomes Riverside Ecological Urban Area Viet Hung Ward, Long Bien District,  VN
Product CodeQFM  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-29
Decision Date2022-09-01

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