Clearance Summary
qCT Lung (v1.0) received FDA 510(k) clearance under submission number K261517, sponsored by Qure.Ai Technologies Pvt. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2026-09-14.
- Submission: K261517
- Applicant / Sponsor: Qure.Ai Technologies Pvt. , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2090
- Decision date: 2026-09-14
Classification & Regulation
This clearance is catalogued under FDA product code QDQ and 21 CFR 892.2090, within the Radiology review panel as a Class II device.