Cleared Traditional

RAYSCAN A-EXPERT 3D

K142247 · Ray Co., Ltd. · Radiology
Apr 2015
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K142247 is an FDA 510(k) clearance for the RAYSCAN A-EXPERT 3D, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Ray Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on April 17, 2015, 262 days after receiving the submission on July 29, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K142247 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2014
Decision Date April 17, 2015
Days to Decision 262 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OAS — X-ray, Tomography, Computed, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.