Cleared Traditional

GT300; GT300-C

K250060 · Genoray Co., Ltd. · Radiology

Oct 2025

Decision

271d

Days

Class 2

Risk

About This 510(k) Submission

K250060 is an FDA 510(k) clearance for the GT300; GT300-C, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Genoray Co., Ltd. (Seongnam-Si, KR). The FDA issued a Cleared decision on October 8, 2025, 271 days after receiving the submission on January 10, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number	K250060 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 2025
Decision Date	October 08, 2025
Days to Decision	271 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.