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FDA 510(k)

Azurion R3.1

K-Number: K251827 · 2025-10-24

ApplicantPhilips Medical Systems B.V.
Decision Date2025-10-24
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Azurion R3.1 is a medical device manufactured by Philips Medical Systems B.V.. It received FDA 510(k) clearance on 2025-10-24 under approval number K251827. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Azurion R3.1?

Azurion R3.1 is a medical device that received FDA 510(k) clearance on 2025-10-24. It is manufactured by Philips Medical Systems B.V.. The 510(k) number is K251827.

When was Azurion R3.1 approved by the FDA?

Azurion R3.1 received FDA 510(k) clearance on 2025-10-24, under approval number K251827.

What company makes Azurion R3.1?

Azurion R3.1 is manufactured by Philips Medical Systems B.V..

What is the FDA product code for Azurion R3.1?

The FDA product code for Azurion R3.1 is OWB.

Other Devices by Philips Medical Systems B.V.

K254186Azurion R3.1

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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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