Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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 2022-05-16 under 510(k) 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. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K213583.

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

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

Who is the listed applicant for Achieva, 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 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.

Other records listing Philips Medical Systems Nederland B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254205Zenition 30K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TK262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TK260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)K253614EchoNavigator R5.0K260169AV Cardiac CT

View all 80 devices →

Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

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.

↑