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FDA 510(k)

Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3

K-Number: K163116 · 2017-01-06

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2017-01-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2017-01-06 under approval number K163116. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3?

Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 is a medical device that received FDA 510(k) clearance on 2017-01-06. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K163116.

When was Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 approved by the FDA?

Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 received FDA 510(k) clearance on 2017-01-06, under approval number K163116.

What company makes Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3?

Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3?

The FDA product code for Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 is LNH.

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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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