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FDA 510(k)

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

K-Number: K193215 · 2020-04-10

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2020-04-10
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Achieva, Intera, Ingenia, Ingneia 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 2020-04-10 under approval number K193215. 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, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems?

Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems is a medical device that received FDA 510(k) clearance on 2020-04-10. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K193215.

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

Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems received FDA 510(k) clearance on 2020-04-10, under approval number K193215.

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

Achieva, Intera, Ingenia, Ingneia 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, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems?

The FDA product code for Achieva, Intera, Ingenia, Ingneia 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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