Cleared Traditional

RIOScan (RPS500)

K160788 · Ray Co., Ltd. · Radiology
Apr 2016
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K160788 is an FDA 510(k) clearance for the RIOScan (RPS500), a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Ray Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on April 15, 2016, 24 days after receiving the submission on March 22, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K160788 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2016
Decision Date April 15, 2016
Days to Decision 24 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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