Azurion R3.1
FDA 510(k) K251827 · Philips Medical Systems B.V.
510(k) numberK251827
Submission
- Device name
- Azurion R3.1
- Applicant
- Philips Medical Systems B.V.
Best, NL - Received
- June 13, 2025
- Decision date
- October 24, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
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| K252229 | Belliger AceOWB · Traditional | Genoray Co., Ltd. | 04/02/2026SE |
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Questions and answers
When was Azurion R3.1 cleared by the FDA?
Azurion R3.1 (K251827) received a 510(k) decision of Substantially Equivalent on October 24, 2025, 133 days after the submission was received.
What is the product code of K251827?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.