Cleared Traditional

K252838 - MAGNETOM Sola (FDA 510(k) Clearance)

Also includes:
MAGNETOM Altea MAGNETOM Sola Fit MAGNETOM Viato.Mobile MAGNETOM Vida MAGNETOM Lumina MAGNETOM Vida Fit MAGNETOM Flow.Elite MAGNETOM Flow.Neo MAGNETOM Flow.Rise

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252838 · Siemens Healthcare GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
105d
Days
Class 2
Risk

K252838 is an FDA 510(k) clearance for the MAGNETOM Sola. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Siemens Healthcare GmbH (Erlanger, DE). The FDA issued a Cleared decision on December 19, 2025 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare GmbH devices

Submission Details

510(k) Number K252838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 107d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LNH System, Nuclear Magnetic Resonance Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Siemens Medical Solutions USA, Inc.
Alina Goodman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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