MAGNETOM Sola +9 more— 510(k) K252838

Name: FDA 510(k) clearance K252838
Creator: U.S. Food and Drug Administration
Published: 2025-12-19

Substantially Equivalent

Siemens Healthcare GmbH

FDA 510(k) clearance K252838 for MAGNETOM Sola +9 more, Substantially Equivalent on 2025-12-19. Applicant: Siemens Healthcare GmbH. Device class: 2.

Clearance details

Device name as filed: MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise
Applicant: Siemens Healthcare GmbH
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2025-09-05
Decision date: 2025-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Erlanger, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code LNH

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K260758 — MAGNETOM Free.Max; MAGNETOM Free.Star2026-09-01
K262622 — Swoop® Portable MR Imaging® System2026-08-19
K254250 — MagicScan-1.5, GreenMR Serenity 1.5T2026-08-17
K253808 — AIR Recon DL2026-08-13
K260852 — MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise; MAGNETOM Flow.Pure2026-07-31

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K253689 — syngo Dynamics (VA41F)2026-04-10
K253057 — AI-Rad Companion Brain MR2026-01-22
K252608 — AI-Rad Companion Prostate MR2025-09-09

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.