Cleared Special

SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC

K141563 · Rayence Co., Ltd. · Radiology
Jul 2014
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K141563 is an FDA 510(k) clearance for the SOLID STATE X-RAY IMAGING DEVICE, DIGITAL FLAT PANEL X-RAY DETECTOR, 1417WGC, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Rayence Co., Ltd. (Houston, US). The FDA issued a Cleared decision on July 16, 2014, 34 days after receiving the submission on June 12, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K141563 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 2014
Decision Date July 16, 2014
Days to Decision 34 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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