uMR Ultra— 510(k) K243547

Name: FDA 510(k) clearance K243547
Creator: U.S. Food and Drug Administration
Published: 2025-07-17

Substantially Equivalent

Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) clearance K243547 for uMR Ultra, Substantially Equivalent on 2025-07-17. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai United Imaging Healthcare Co., Ltd.
Product code: Code LNH
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2024-11-15
Decision date: 2025-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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K254250 — MagicScan-1.5, GreenMR Serenity 1.5T2026-08-17
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K261331 — I-Genius (100019400)2026-07-31

More clearances from Shanghai United Imaging Healthcare Co., Ltd.

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K253726 — uAngio AVIVA CX2026-08-21
K261427 — uMI Panvivo (uMI Panvivo M)2026-07-28
K260113 — uMR Astra2026-05-22
K253077 — uOmnispace.MR2026-04-22
K260524 — uMI Panvivo (5 models)2026-04-03

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.