FDA 510(k)

qCT Lung (v1.0)

Número K: K261517 · 2026-09-14

RequerenteQure.Ai Technologies Pvt. , Ltd.

Data da decisão2026-09-14

Código do produtoQDQ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

qCT Lung (v1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Qure.Ai Technologies Pvt. , Ltd.. It received FDA 510(k) clearance on 2026-09-14 under 510(k) number K261517. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the qCT Lung (v1.0)?

qCT Lung (v1.0) is a medical device that received FDA 510(k) clearance on 2026-09-14. The listed applicant is Qure.Ai Technologies Pvt. , Ltd.. The 510(k) number is K261517.

When did qCT Lung (v1.0) receive FDA 510(k) clearance?

qCT Lung (v1.0) received FDA 510(k) clearance on 2026-09-14, under 510(k) number K261517.

Who is the listed applicant for qCT Lung (v1.0)?

The FDA 510(k) record lists Qure.Ai Technologies Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for qCT Lung (v1.0)?

The FDA product code for qCT Lung (v1.0) is QDQ.

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Fonte oficial

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