qCT Lung (v1.0)— 510(k) K261517

Name: FDA 510(k) clearance K261517
Creator: U.S. Food and Drug Administration
Published: 2026-09-14

Substantially Equivalent

Qure.Ai Technologies Pvt. , Ltd.

FDA 510(k) clearance K261517 for qCT Lung (v1.0), Substantially Equivalent on 2026-09-14. Applicant: Qure.Ai Technologies Pvt. , Ltd.. Device class: 2.

Clearance details

Applicant: Qure.Ai Technologies Pvt. , Ltd.
Product code: Code QDQ
Device class: Class 2
Regulation: 21 CFR 892.2090
Advisory panel: Radiology
Date received: 2026-05-07
Decision date: 2026-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mumbai, IN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.