Cleared Traditional

MAGNETOM Free.Max; MAGNETOM Free.Star

K251822 · Siemens Shenzhen Magnetic Resonance , Ltd. · Radiology

Nov 2025

Decision

160d

Days

Class 2

Risk

About This 510(k) Submission

K251822 is an FDA 510(k) clearance for the MAGNETOM Free.Max; MAGNETOM Free.Star, a System, Nuclear Magnetic Resonance Imaging (Class II — Special Controls, product code LNH), submitted by Siemens Shenzhen Magnetic Resonance , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 20, 2025, 160 days after receiving the submission on June 13, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number	K251822 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2025
Decision Date	November 20, 2025
Days to Decision	160 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF