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FDA 510(k)

Allura Xper FD series and Allura Xper OR Table series

K-Number: K162859 · 2016-12-02

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2016-12-02
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Allura Xper FD series and Allura Xper OR Table series is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2016-12-02 under 510(k) number K162859. 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 FD series and Allura Xper OR Table series?

Allura Xper FD series and Allura Xper OR Table series is a medical device that received FDA 510(k) clearance on 2016-12-02. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K162859.

When did Allura Xper FD series and Allura Xper OR Table series receive FDA 510(k) clearance?

Allura Xper FD series and Allura Xper OR Table series received FDA 510(k) clearance on 2016-12-02, under 510(k) number K162859.

Who is the listed applicant for Allura Xper FD series and Allura Xper OR Table series?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Allura Xper FD series and Allura Xper OR Table series?

The FDA product code for Allura Xper FD series and Allura Xper OR Table series is OWB.

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Official Source

View on FDA Database →

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