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 · System, Nuclear Magnetic Resonance Imaging

What it does

Supports the imaging workflow around multi-modality studies — routing, scheduling, or image management — rather than interpreting the images.

Who it's for

Imaging departments and informatics teams managing study flow.

Reported performance

No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics — we note that honestly rather than imply a number.

Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.

FDA

Pathway510(k)

Submission #K252838

Product codeLNH

Decision dateDec 19, 2025

PanelRadiology

FDA recordaccessdata

EU (CE)

Statusunknown

Risk class—

Notified body—

EMDN code—

Basic UDI-DI—

AI Act class—

EU coverage is filling out through 2026; absence here doesn't mean a device isn't CE-marked.

Vendor

Company🇩🇪Siemens Healthcare GmbH

Founded2017-12-01 · via wikidata

Websitesiemens-healthineers.com

Cite this page

RadPigeon. "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)." AI Devices registry. https://radpigeon.news/ai/device/magnetom-sola-magnetom-altea-magnetom-sola-fit-magnetom-viato-mobile-magnetom-vi

Last updated Jun 29, 2026. Information only — not clinical advice. Summaries are RadPigeon's own wording.