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FDA 510(k)

Ingenia 1.5T and Ingenia 1.5T S R5.2

K-Number: K153324 · 2016-03-22

ApplicantPhilips Medical Systems Nederlands B.V.
Decision Date2016-03-22
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ingenia 1.5T and Ingenia 1.5T S R5.2 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederlands B.V.. It received FDA 510(k) clearance on 2016-03-22 under 510(k) number K153324. 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 and Ingenia 1.5T S R5.2?

Ingenia 1.5T and Ingenia 1.5T S R5.2 is a medical device that received FDA 510(k) clearance on 2016-03-22. The listed applicant is Philips Medical Systems Nederlands B.V.. The 510(k) number is K153324.

When did Ingenia 1.5T and Ingenia 1.5T S R5.2 receive FDA 510(k) clearance?

Ingenia 1.5T and Ingenia 1.5T S R5.2 received FDA 510(k) clearance on 2016-03-22, under 510(k) number K153324.

Who is the listed applicant for Ingenia 1.5T and Ingenia 1.5T S R5.2?

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

What is the FDA product code for Ingenia 1.5T and Ingenia 1.5T S R5.2?

The FDA product code for Ingenia 1.5T and Ingenia 1.5T S R5.2 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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