Cleared Special

RAYSCAN a-Expert3D

K190812 · Ray Co., Ltd. · Radiology
Apr 2019
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K190812 is an FDA 510(k) clearance for the RAYSCAN a-Expert3D, 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 24, 2019, 26 days after receiving the submission on March 29, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K190812 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2019
Decision Date April 24, 2019
Days to Decision 26 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.