FDA 510(k)

CT:VQ

Número K: K251484 · 2025-08-28

Data da decisão2025-08-28

Código do produtoJAK

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

CT:VQ is the device name listed in this FDA 510(k) record. The listed applicant is 4Dmedical Limited. It received FDA 510(k) clearance on 2025-08-28 under 510(k) number K251484. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CT:VQ?

CT:VQ is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is 4Dmedical Limited. The 510(k) number is K251484.

When did CT:VQ receive FDA 510(k) clearance?

CT:VQ received FDA 510(k) clearance on 2025-08-28, under 510(k) number K251484.

Who is the listed applicant for CT:VQ?

The FDA 510(k) record lists 4Dmedical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT:VQ?

The FDA product code for CT:VQ is JAK.

Outros registros que listam 4Dmedical Limited como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K232392CT Lung Ventilation Analysis Software (CT:V)

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Fonte oficial

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