Cleared Special

Green X 12 SE (PHT-40CHS)

K243088 · VATECH Co., Ltd. · Radiology
Feb 2025
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K243088 is an FDA 510(k) clearance for the Green X 12 SE (PHT-40CHS), a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by VATECH Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on February 21, 2025, 144 days after receiving the submission on September 30, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K243088 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2024
Decision Date February 21, 2025
Days to Decision 144 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.