Cleared Traditional

RAYSCAN A-EXPERT

K122918 · Ray Co., Ltd. · Radiology
Mar 2013
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K122918 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. (Beverly Hills, US). The FDA issued a Cleared decision on March 15, 2013, 172 days after receiving the submission on September 24, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K122918 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2012
Decision Date March 15, 2013
Days to Decision 172 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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