qER-Quant— 510(k) K211222

Substantially Equivalent

Qure.Ai Technologies

FDA 510(k) clearance K211222 for qER-Quant, Substantially Equivalent on 2021-07-30. Applicant: Qure.Ai Technologies. Device class: 2.

Clearance details

Applicant: Qure.Ai Technologies
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2021-04-23
Decision date: 2021-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mumbai, IN

Download summary PDF View on FDA.gov ↗

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