Cleared Special

RAYSCAN a-Expert3D

K232287 · Ray Co., Ltd. · Radiology
Aug 2023
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K232287 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. (Yongin-Si, KR). The FDA issued a Cleared decision on August 31, 2023, 30 days after receiving the submission on August 1, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K232287 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2023
Decision Date August 31, 2023
Days to Decision 30 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.