MAGNETOM Free.Max; MAGNETOM Free.Star— 510(k) K260758
Substantially EquivalentSiemens Shenzhen Magnetic Resonance , Ltd.
FDA 510(k) clearance K260758 for MAGNETOM Free.Max; MAGNETOM Free.Star, Substantially Equivalent on 2026-09-01. Applicant: Siemens Shenzhen Magnetic Resonance , Ltd.. Device class: 2.
Summary
MAGNETOM Free.Max and MAGNETOM Free.Star are from Siemens Shenzhen Magnetic Resonance, Ltd., filed under product code LNH (System, Nuclear Magnetic Resonance Imaging). The record doesn't say how the two systems differ.
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Siemens filed from Shenzhen, China. The decision came 176 calendar days after FDA received it (March 9 to September 1, 2026).
Clearance details
- Applicant
- Siemens Shenzhen Magnetic Resonance , Ltd.
- Product code
- Product code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code LNH
view allMore clearances from Siemens Shenzhen Magnetic Resonance , Ltd.
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.