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FDA 510(k)

EchoNavigator R5.0

K-Number: K253614 · 2026-03-17

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2026-03-17
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the EchoNavigator R5.0?

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

When was EchoNavigator R5.0 approved by the FDA?

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

What company makes EchoNavigator R5.0?

EchoNavigator R5.0 is manufactured by Philips Medical Systems Nederland B.V..

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

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

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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