MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise

Siemens Healthcare GmbH · K252838 · 2025-12-19

MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise is an AI-enabled medical device from Siemens Healthcare GmbH, listed by FDA (510(k), K252838) with a decision date of 2025-12-19. Review panel: Radiology.

FDA submission numberK252838
Pathway510(k)
CompanySiemens Healthcare GmbH
Review panel (specialty)Radiology
FDA decision date2025-12-19
DecisionSubstantially Equivalent
Product codeLNH
ClassificationSystem, Nuclear Magnetic Resonance Imaging
Device class2
Regulation number892.1000
Review time (calendar days)105
Applicant countryDE

Official FDA database record · FDA AI-enabled device list

More devices from Siemens Healthcare GmbH · All Radiology AI devices · Full device index

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