Cleared Special

RCT800

K230753 · Ray Co., Ltd. · Radiology
Apr 2023
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K230753 is an FDA 510(k) clearance for the RCT800, 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 April 11, 2023, 25 days after receiving the submission on March 17, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K230753 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2023
Decision Date April 11, 2023
Days to Decision 25 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.