MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

FDA 510(k) K260265 · Siemens Shenzhen Magnetic Resonance , Ltd.

Substantially Equivalent

510(k) numberK260265

Submission

Device name
MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
Applicant
Siemens Shenzhen Magnetic Resonance , Ltd.
Shenzhen, CN
Received
January 28, 2026
Decision date
February 23, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LNH – System, Nuclear Magnetic Resonance Imaging
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1000
Specialty
Radiology

Other 510(k)s with product code LNH

510(k)DeviceApplicantDecision
K260758MAGNETOM Free.Max; MAGNETOM Free.StarLNH · Traditional Siemens Shenzhen Magnetic Resonance , Ltd.09/01/2026SE
K262622Swoop® Portable MR Imaging® SystemLNH · Special Hyperfine, Inc.08/19/2026SE
K254250MagicScan-1.5, GreenMR Serenity 1.5TLNH · Traditional Xingaoyi Medical Equipment Co.,Ltd08/17/2026SE
K253808AIR Recon DLLNH · Traditional GE Medical Systems08/13/2026SE
K261331I-Genius (100019400)LNH · Traditional Esaote, S.p.A.07/31/2026SE
K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureLNH · Traditional Siemens Healthineers AG07/31/2026SE
K260113uMR AstraLNH · Traditional Shanghai United Imaging Healthcare Co., Ltd.05/22/2026SE
K253862APERTO Lucent MRI SystemLNH · Traditional Fujifilm Corporation04/06/2026SE
K260746S-scan Open (100001800)LNH · Special Esaote, S.p.A.03/27/2026SE
K253625Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…LNH · Traditional Canon Medical Systems Corporation03/27/2026SE

More from Canon Medical Systems Corporation

510(k)DeviceDecision
K260758MAGNETOM Free.Max; MAGNETOM Free.StarLNH · Traditional 09/01/2026SE
K251822MAGNETOM Free.Max; MAGNETOM Free.StarLNH · Traditional 11/20/2025SE
K250436MAGNETOM Flow.Ace; MAGNETOM Flow.PlusLNH · Traditional 06/16/2025SE

Questions and answers

When was MAGNETOM Flow.Ace; MAGNETOM Flow.Plus cleared by the FDA?

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (K260265) received a 510(k) decision of Substantially Equivalent on February 23, 2026, 26 days after the submission was received.

What is the product code of K260265?

The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.