Cleared Traditional

K250443 - MAGNETOM Avanto Fit (FDA 510(k) Clearance)

Also includes:
MAGNETOM Skyra Fit MAGNETOM Sola Fit MAGNETOM Viato.Mobile

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

K250443 · Siemens Healthcare GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
122d
Days
Class 2
Risk

K250443 is an FDA 510(k) clearance for the MAGNETOM Avanto Fit. Classified as System, Nuclear Magnetic Resonance Imaging (product code LNH), Class II - Special Controls.

Submitted by Siemens Healthcare GmbH (Erlangen, DE). The FDA issued a Cleared decision on June 16, 2025 after a review of 122 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 K250443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 107d · This submission: 122d
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.

Regulatory Peers - LNH System, Nuclear Magnetic Resonance Imaging

All 1097
Devices cleared under the same product code (LNH) and FDA review panel - the closest regulatory comparables to K250443.
APERTO Lucent MRI System
K253862 · Fujifilm Corporation · Apr 2026
S-scan Open (100001800)
K260746 · Esaote, S.P.A. · Mar 2026
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR
K253625 · Canon Medical Systems Corporation · Mar 2026
nordicAudio (1.0)
K251937 · Nordicneurolab AS · Mar 2026
Embrace Neonatal MRI System
K254277 · Aspect Imaging, Ltd. · Mar 2026
LiverMultiScan (v6.0)
K253413 · Perspectum, Ltd. · Mar 2026