Cleared Special

RAYSCAN A-EXPERT 3D

K131695 · Ray Co., Ltd. · Radiology
Nov 2013
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K131695 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. (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 892.1750.

Submission Details

510(k) Number K131695 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 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.