FDA 510(k)

Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems

K-Number: K183063 · 2019-02-14

ApplicantPhilips Medical Systems Nederland B.V.

Decision Date2019-02-14

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems 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 2019-02-14 under 510(k) number K183063. 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, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems?

Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems is a medical device that received FDA 510(k) clearance on 2019-02-14. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K183063.

When did Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems receive FDA 510(k) clearance?

Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems received FDA 510(k) clearance on 2019-02-14, under 510(k) number K183063.

Who is the listed applicant for Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems?

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, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems?

The FDA product code for Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems 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.