MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure— 510(k) K260852
Substantially EquivalentSiemens Healthineers AG
FDA 510(k) clearance K260852 for MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure, Substantially Equivalent on 2026-07-31. Applicant: Siemens Healthineers AG. Device class: 2.
Summary
Siemens Healthineers' clearance covers four MAGNETOM Flow systems: Flow.Elite, Flow.Neo, Flow.Rise, and Flow.Pure. They're filed under LNH, nuclear magnetic resonance imaging systems, and the record doesn't say how the four differ.
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel, and it was a Traditional 510(k).
Siemens Healthineers filed from Forchheim, Germany. The decision came 137 calendar days after FDA received it (March 16 to July 31, 2026).
Clearance details
- Device name as filed
- MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure
- Applicant
- Siemens Healthineers AG
- 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
- Forchheim, DE
Recent devices under product code LNH
view allMore clearances from Siemens Healthineers AG
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.