FDA 510(k)

Dendrite Imaging System

Número K: K253303 · 2025-11-28

Data da decisão2025-11-28

Código do produtoQDG

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dendrite Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Dendrite Imaging, Inc.. It received FDA 510(k) clearance on 2025-11-28 under 510(k) number K253303. The device is classified under product code QDG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dendrite Imaging System?

Dendrite Imaging System is a medical device that received FDA 510(k) clearance on 2025-11-28. The listed applicant is Dendrite Imaging, Inc.. The 510(k) number is K253303.

When did Dendrite Imaging System receive FDA 510(k) clearance?

Dendrite Imaging System received FDA 510(k) clearance on 2025-11-28, under 510(k) number K253303.

Who is the listed applicant for Dendrite Imaging System?

The FDA 510(k) record lists Dendrite Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dendrite Imaging System?

The FDA product code for Dendrite Imaging System is QDG.

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