Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems

Philips Medical Systems Nederland B.V. · K223458 · 2023-04-06

Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems is an AI-enabled medical device from Philips Medical Systems Nederland B.V., listed by FDA (510(k), K223458) with a decision date of 2023-04-06. Review panel: Radiology.

FDA submission numberK223458
Pathway510(k)
CompanyPhilips Medical Systems Nederland B.V.
Review panel (specialty)Radiology
FDA decision date2023-04-06
DecisionSubstantially Equivalent
Product codeLNH
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Device class2
Regulation number892.1000
Review time (calendar days)141
Applicant countryNL

Official FDA database record · FDA AI-enabled device list

More devices from Philips Medical Systems Nederland B.V. · All Radiology AI devices · Full device index

Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.