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FDA 510(k)

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

K-Number: K213583 · 2022-05-16

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2022-05-16
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2022-05-16 under approval number K213583. 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 Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems?

Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems is a medical device that received FDA 510(k) clearance on 2022-05-16. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K213583.

When was Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems approved by the FDA?

Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems received FDA 510(k) clearance on 2022-05-16, under approval number K213583.

What company makes Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems?

Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems is manufactured by Philips Medical Systems Nederland B.V..

What is the FDA product code for Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems?

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