Azurion R2.0
FDA 510(k) K181830 · Philips Medical Systems Nederland B.V.
510(k) numberK181830
Submission
- Device name
- Azurion R2.0
- Applicant
- Philips Medical Systems Nederland B.V.
Best Noord-Brabant, NL - Received
- July 9, 2018
- Decision date
- August 2, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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More from Genoray Co., Ltd.
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Questions and answers
When was Azurion R2.0 cleared by the FDA?
Azurion R2.0 (K181830) received a 510(k) decision of Substantially Equivalent on August 2, 2018, 24 days after the submission was received.
What is the product code of K181830?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.