qER-CTA (v1.0)— 510(k) K251610

Substantially Equivalent

Qure.Ai Technologies

FDA 510(k) clearance K251610 for qER-CTA (v1.0), Substantially Equivalent on 2025-09-08. 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: 2025-05-27
Decision date: 2025-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mumbai, IN

Download summary PDF View on FDA.gov ↗

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