MAGNETOM Free.Max; MAGNETOM Free.Star

Q: What is the product code of K260758?

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

FDA 510(k) K260758 · Siemens Shenzhen Magnetic Resonance , Ltd.

Substantially Equivalent

510(k) numberK260758

Submission

Device name: MAGNETOM Free.Max; MAGNETOM Free.Star
Applicant: Siemens Shenzhen Magnetic Resonance , Ltd.
Shenzhen, CN
Received: March 9, 2026
Decision date: September 1, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 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)	Device	Applicant	Decision
K262622	Swoop® Portable MR Imaging® SystemLNH · Special	Hyperfine, Inc.	08/19/2026SE
K254250	MagicScan-1.5, GreenMR Serenity 1.5TLNH · Traditional	Xingaoyi Medical Equipment Co.,Ltd	08/17/2026SE
K253808	AIR Recon DLLNH · Traditional	GE Medical Systems	08/13/2026SE
K261331	I-Genius (100019400)LNH · Traditional	Esaote, S.p.A.	07/31/2026SE
K260852	MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureLNH · Traditional	Siemens Healthineers AG	07/31/2026SE
K260113	uMR AstraLNH · Traditional	Shanghai United Imaging Healthcare Co., Ltd.	05/22/2026SE
K253862	APERTO Lucent MRI SystemLNH · Traditional	Fujifilm Corporation	04/06/2026SE
K260746	S-scan Open (100001800)LNH · Special	Esaote, S.p.A.	03/27/2026SE
K253625	Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for…LNH · Traditional	Canon Medical Systems Corporation	03/27/2026SE
K251937	nordicAudio (1.0)LNH · Traditional	Nordicneurolab AS	03/20/2026SE

More from Nordicneurolab AS

510(k)	Device	Decision
K260265	MAGNETOM Flow.Ace; MAGNETOM Flow.PlusLNH · Special	02/23/2026SE
K251822	MAGNETOM Free.Max; MAGNETOM Free.StarLNH · Traditional	11/20/2025SE
K250436	MAGNETOM Flow.Ace; MAGNETOM Flow.PlusLNH · Traditional	06/16/2025SE

Questions and answers

When was MAGNETOM Free.Max; MAGNETOM Free.Star cleared by the FDA?

MAGNETOM Free.Max; MAGNETOM Free.Star (K260758) received a 510(k) decision of Substantially Equivalent on September 1, 2026, 176 days after the submission was received.

What is the product code of K260758?

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