Cleared Traditional

RIS500

K143000 · Ray Co., Ltd. · Radiology
Jan 2015
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K143000 is an FDA 510(k) clearance for the RIS500, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Ray Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on January 23, 2015, 98 days after receiving the submission on October 17, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K143000 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2014
Decision Date January 23, 2015
Days to Decision 98 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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