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

Philips Medical Systems Nederland B.V. · K213583 · 2022-05-16

Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems is an AI-enabled medical device from Philips Medical Systems Nederland B.V., listed by FDA (510(k), K213583) with a decision date of 2022-05-16. Review panel: Radiology.

FDA submission numberK213583
Pathway510(k)
CompanyPhilips Medical Systems Nederland B.V.
Review panel (specialty)Radiology
FDA decision date2022-05-16
DecisionSubstantially Equivalent
Product codeLNH
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Device class2
Regulation number892.1000
Review time (calendar days)185
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.