2430TCA with Xmaru W— 510(k) K243849

Name: FDA 510(k) clearance K243849
Creator: U.S. Food and Drug Administration
Published: 2025-03-12

Substantially Equivalent

Rayence Co., Ltd.

FDA 510(k) clearance K243849 for 2430TCA with Xmaru W, Substantially Equivalent on 2025-03-12. Applicant: Rayence Co., Ltd.. Device class: 2.

Clearance details

Applicant: Rayence Co., Ltd.
Product code: Code MUE
Device class: Class 2
Regulation: 21 CFR 892.1715
Advisory panel: Radiology
Date received: 2024-12-16
Decision date: 2025-03-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MUE

product code MUE

Death: 5
Other: 1
Total: 6

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.