Cleared Special

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

K260265 · Siemens Shenzhen Magnetic Resonance , Ltd. · Radiology

Feb 2026

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K260265 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 February 23, 2026, 26 days after receiving the submission on January 28, 2026. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1000.

Submission Details

510(k) Number	K260265 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 2026
Decision Date	February 23, 2026
Days to Decision	26 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF