FDA 510(k)

EchoNavigator R5.0

Número K: K253614 · 2026-03-17

RequerentePhilips Medical Systems Nederland B.V.

Data da decisão2026-03-17

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

EchoNavigator R5.0 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2026-03-17 under 510(k) number K253614. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EchoNavigator R5.0?

EchoNavigator R5.0 is a medical device that received FDA 510(k) clearance on 2026-03-17. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K253614.

When did EchoNavigator R5.0 receive FDA 510(k) clearance?

EchoNavigator R5.0 received FDA 510(k) clearance on 2026-03-17, under 510(k) number K253614.

Who is the listed applicant for EchoNavigator R5.0?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EchoNavigator R5.0?

The FDA product code for EchoNavigator R5.0 is QIH.

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Fonte oficial

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