K-number	K251827
Device name	Azurion R3.1
Applicant	Philips Medical Systems B.V.
Product code	OWB
Device class	Class II
Decision date	Oct 24, 2025
Decision	Substantially Equivalent
Regulation	892.1650

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Azurion R3.1

Everything you need for a 510(k) submission. Nothing you don't.