qXR-BT— 510(k) K212690

Substantially Equivalent

Qure.Ai Technologies

FDA 510(k) clearance K212690 for qXR-BT, Substantially Equivalent on 2021-12-21. 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: 2021-08-25
Decision date: 2021-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mumbai, IN

Download summary PDF View on FDA.gov ↗

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