Cleared Special

Grreen X 12 (Model: PHT-75CHS)

K231796 · VATECH Co., Ltd. · Radiology
Jul 2023
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K231796 is an FDA 510(k) clearance for the Grreen X 12 (Model: PHT-75CHS), 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 July 19, 2023, 29 days after receiving the submission on June 20, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K231796 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2023
Decision Date July 19, 2023
Days to Decision 29 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.