Cleared Traditional

RAYSCAN A-EXPERT 3D

K122981 · Ray Co., Ltd. · Radiology
Mar 2013
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K122981 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. (Beverly Hills, US). The FDA issued a Cleared decision on March 12, 2013, 169 days after receiving the submission on September 24, 2012. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K122981 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2012
Decision Date March 12, 2013
Days to Decision 169 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.