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The Tracker / September 2026 / K261517

510(k) cleared

qCT Lung (v1.0)

Qure.Ai Technologies Pvt. , Ltd. · Sep 14, 2026 · K261517

FDA cleared the qCT Lung (v1.0) from Qure.Ai Technologies Pvt. , Ltd. on Sep 14, 2026 under K261517, a traditional 510(k). The device falls under product code QDQ, Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, regulated at 21 CFR 892.2090 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on May 7, 2026. The decision came 130 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Qure.Ai Technologies Pvt. , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261517?

K261517 is the FDA 510(k) for qCT Lung (v1.0), submitted by Qure.Ai Technologies Pvt. , Ltd.. FDA's decision date was Sep 14, 2026, under product code QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer).

Who makes the qCT Lung (v1.0)?

Qure.Ai Technologies Pvt. , Ltd., based in Mumbai, is the applicant of record for K261517.

How long did the K261517 review take?

FDA received the submission on May 7, 2026 and issued its decision on Sep 14, 2026, 130 days later.

← All decisions in September 2026