Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System

Philips Medical Systems Nederland B.V. · K251397 · 2025-06-04

Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System is an AI-enabled medical device from Philips Medical Systems Nederland B.V., listed by FDA (510(k), K251397) with a decision date of 2025-06-04. Review panel: Radiology.

FDA submission numberK251397
Pathway510(k)
CompanyPhilips Medical Systems Nederland B.V.
Review panel (specialty)Radiology
FDA decision date2025-06-04
DecisionSubstantially Equivalent
Product codeLNH
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Device class2
Regulation number892.1000
Review time (calendar days)29
Applicant countryNL

Official FDA database record · FDA AI-enabled device list

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