MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure— 510(k) K260852

Name: FDA 510(k) clearance K260852
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Substantially Equivalent

Siemens 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.

Clearance details

Device name as filed: MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.Pure
Applicant: Siemens Healthineers AG
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2026-03-16
Decision date: 2026-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Forchheim, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNH

view all

K262622 — Swoop® Portable MR Imaging® System2026-08-19
K254250 — MagicScan-1.5, GreenMR Serenity 1.5T2026-08-17
K253808 — AIR Recon DL2026-08-13
K261331 — I-Genius (100019400)2026-07-31
K260113 — uMR Astra2026-05-22

More clearances from Siemens Healthineers AG

view all

K253690 — LungMaps2026-06-15
K253023 — BIOGRAPH One2026-01-15
K253495 — syngo.MR Applications (VB80)2025-11-20
K251059 — Syngo Carbon Clinicals (VA41)2025-10-24

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.