Cleared Traditional

RAYSCAN A-EXPERT

K142058 · Ray Co., Ltd. · Radiology
Apr 2015
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K142058 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 April 22, 2015, 267 days after receiving the submission on July 29, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K142058 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2014
Decision Date April 22, 2015
Days to Decision 267 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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