Cleared Traditional

RCT600

K243903 · Ray Co., Ltd. · Radiology
Mar 2025
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K243903 is an FDA 510(k) clearance for the RCT600, 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 March 12, 2025, 83 days after receiving the submission on December 19, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K243903 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2024
Decision Date March 12, 2025
Days to Decision 83 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.