Cleared Special

1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF

K231467 · Rayence Co., Ltd. · Radiology
Jun 2023
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K231467 is an FDA 510(k) clearance for the 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-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 June 21, 2023, 30 days after receiving the submission on May 22, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K231467 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2023
Decision Date June 21, 2023
Days to Decision 30 days
Submission Type Special
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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