Azurion R2.1
K-Number: K200917 · 2020-05-01
Decision Date2020-05-01
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Azurion R2.1 is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2020-05-01 under approval number K200917. 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 R2.1?
Azurion R2.1 is a medical device that received FDA 510(k) clearance on 2020-05-01. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K200917.
When was Azurion R2.1 approved by the FDA?
Azurion R2.1 received FDA 510(k) clearance on 2020-05-01, under approval number K200917.
What company makes Azurion R2.1?
Azurion R2.1 is manufactured by Philips Medical Systems Nederland B.V..
What is the FDA product code for Azurion R2.1?
The FDA product code for Azurion R2.1 is OWB.
Other Devices by Philips Medical Systems Nederland B.V.
Related Devices (Code: OWB)
K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.
K162148Allura Xper R9Philips Medical Systems Nethrlands BV
K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation
K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd.
K161976Ziehm Solo FDZiehm Imaging GmbH
K161756SyncVision SystemVolcano Corporation
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.