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FDA 510(k)

Allura Xper R9

K-Number: K162148 · 2016-11-23

ApplicantPhilips Medical Systems Nethrlands BV
Decision Date2016-11-23
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Allura Xper R9 is a medical device manufactured by Philips Medical Systems Nethrlands BV. It received FDA 510(k) clearance on 2016-11-23 under approval number K162148. 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 Allura Xper R9?

Allura Xper R9 is a medical device that received FDA 510(k) clearance on 2016-11-23. It is manufactured by Philips Medical Systems Nethrlands BV. The 510(k) number is K162148.

When was Allura Xper R9 approved by the FDA?

Allura Xper R9 received FDA 510(k) clearance on 2016-11-23, under approval number K162148.

What company makes Allura Xper R9?

Allura Xper R9 is manufactured by Philips Medical Systems Nethrlands BV.

What is the FDA product code for Allura Xper R9?

The FDA product code for Allura Xper R9 is OWB.

Related Devices (Code: OWB)

K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. K162614Infinix, INFX-8000V, V6.35Toshibamedical Systems Corporation K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. K161976Ziehm Solo FDZiehm Imaging GmbH K161756SyncVision SystemVolcano Corporation K160455AneurysmFlowPhilips Medical Systems Nederland B.V.

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.

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