Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)— 510(k) K242394

Name: FDA 510(k) clearance K242394
Creator: U.S. Food and Drug Administration
Published: 2024-09-09

Substantially Equivalent

Rayence Co., Ltd.

FDA 510(k) clearance K242394 for Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF), Substantially Equivalent on 2024-09-09. 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: 2024-08-13
Decision date: 2024-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong-Si, KR

Download summary PDF View on FDA.gov ↗

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