qER— 510(k) K200921

Substantially Equivalent

Qure.Ai Technologies

FDA 510(k) clearance K200921 for qER, Substantially Equivalent on 2020-06-17. Applicant: Qure.Ai Technologies. Device class: 2.

Clearance details

Applicant: Qure.Ai Technologies
Product code: Code QAS
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2020-04-06
Decision date: 2020-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mumbai, IN

Download summary PDF View on FDA.gov ↗

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