FDA 510(k)

Azurion R3.1

K-Number: K251827 · 2025-10-24

Decision Date2025-10-24

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Azurion R3.1 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems B.V.. It received FDA 510(k) clearance on 2025-10-24 under 510(k) 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. The listed applicant is Philips Medical Systems B.V.. The 510(k) number is K251827.

When did Azurion R3.1 receive FDA 510(k) clearance?

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

Who is the listed applicant for Azurion R3.1?

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

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

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

Other records listing Philips Medical Systems B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253670SmartCT (R3.0 (L10))K254186Azurion R3.1

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Official Source

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