Cleared Traditional

MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile

K250443 · Siemens Healthcare GmbH · Radiology
Jun 2025
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K250443 is an FDA 510(k) clearance for the MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Siemens Healthcare GmbH (Erlangen, DE). The FDA issued a Cleared decision on June 16, 2025, 122 days after receiving the submission on February 14, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number K250443 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2025
Decision Date June 16, 2025
Days to Decision 122 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LNH — System, Nuclear Magnetic Resonance Imaging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1000

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