MAGNETOM Flow.Ace; MAGNETOM Flow.Plus— 510(k) K260265

Substantially Equivalent

Siemens 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..

Clearance details

Applicant: Siemens Shenzhen Magnetic Resonance , Ltd.
Product code: Code LNH
Advisory panel: Radiology
Date received: 2026-01-28
Decision date: 2026-02-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNH

product code LNH

Death: 11
Injury: 670
Malfunction: 1,460
Other: 2
Total: 2,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.