MAGNETOM Flow.Ace; MAGNETOM Flow.Plus— 510(k) K260265
Substantially EquivalentSiemens Shenzhen Magnetic Resonance , Ltd.
FDA 510(k) clearance K260265 for MAGNETOM Flow.Ace; MAGNETOM Flow.Plus, Substantially Equivalent on 2026-02-23. Applicant: Siemens Shenzhen Magnetic Resonance , Ltd.. Device class: 2.
Summary
Siemens Shenzhen Magnetic Resonance lists two systems, MAGNETOM Flow.Ace and MAGNETOM Flow.Plus, under product code LNH, nuclear magnetic resonance imaging system. The record doesn't say how they differ.
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel. It came in as a Special 510(k).
Siemens Shenzhen Magnetic Resonance filed from Shenzhen, China. Review took 26 calendar days (January 28 to February 23, 2026), ending in a substantially equivalent decision.
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
- Special
- 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.