Cleared Traditional

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

K252838 · Siemens Healthcare GmbH · Radiology

Dec 2025

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K252838 is an FDA 510(k) clearance for the 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, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Siemens Healthcare GmbH (Erlanger, DE). The FDA issued a Cleared decision on December 19, 2025, 105 days after receiving the submission on September 5, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number	K252838 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 05, 2025
Decision Date	December 19, 2025
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF