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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 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 2017-01-06 under 510(k) 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. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K163116.

When did Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 receive FDA 510(k) clearance?

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

Who is the listed applicant for Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3?

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 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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