Cleared Traditional

RCT700

K251798 · Ray Co., Ltd. · Radiology

Nov 2025

Decision

166d

Days

Class 2

Risk

About This 510(k) Submission

K251798 is an FDA 510(k) clearance for the RCT700, 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 November 25, 2025, 166 days after receiving the submission on June 12, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number	K251798 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 12, 2025
Decision Date	November 25, 2025
Days to Decision	166 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.