QER

Radiological Computer-assisted Triage And Notification Software

Qure.ai Technologies

The following data is part of a premarket notification filed by Qure.ai Technologies with the FDA for Qer.

Pre-market Notification Details

Device IDK200921
510k NumberK200921
Device Name:QER
ClassificationRadiological Computer-assisted Triage And Notification Software
Applicant Qure.ai Technologies Level 7, Commerz II, International Business Park, Oberoi Garden City, Mumbai,  IN 400063
ContactPooja Rao
CorrespondentPooja Rao
Qure.ai Technologies Level 7, Commerz II, International Business Park, Oberoi Garden City, Mumbai,  IN 400063
Product CodeQAS  
CFR Regulation Number892.2080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-06
Decision Date2020-06-17

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