Cleared Traditional

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

K250436 · Siemens Shenzhen Magnetic Resonance , Ltd. · Radiology

Jun 2025

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K250436 is an FDA 510(k) clearance for the MAGNETOM Flow.Ace; MAGNETOM Flow.Plus, 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 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	K250436 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