0909FCE, 0909FCE-HS— 510(k) K253800

Substantially Equivalent

Rayence Co., Ltd.

FDA 510(k) clearance K253800 for 0909FCE, 0909FCE-HS, Substantially Equivalent on 2026-07-31. Applicant: Rayence Co., Ltd.. Device class: 2.

Clearance details

Applicant: Rayence Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2025-11-28
Decision date: 2026-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Rayence Co., Ltd.

K243849 — 2430TCA with Xmaru W2025-03-12
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K240371 — 0909FCC, 0909FCC-HS2024-03-07
K231467 — 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF2023-06-21
K220689 — Vatech Clismile2022-05-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.