Cleared Special

RAYSCAN A-EXPERT

K131693 · Ray Co., Ltd. · Radiology
Nov 2013
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K131693 is an FDA 510(k) clearance for the RAYSCAN A-EXPERT, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Ray Co., Ltd. (Santa Rosa, US). The FDA issued a Cleared decision on November 1, 2013, 144 days after receiving the submission on June 10, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K131693 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2013
Decision Date November 01, 2013
Days to Decision 144 days
Submission Type Special
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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