Cleared Traditional

Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)

K242394 · Rayence Co., Ltd. · Radiology
Sep 2024
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K242394 is an FDA 510(k) clearance for the Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF), a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Rayence Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on September 9, 2024, 27 days after receiving the submission on August 13, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K242394 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2024
Decision Date September 09, 2024
Days to Decision 27 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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