Cleared Special

Green Smart (Model: PHT-35LHS)

K162660 · VATECH Co., Ltd. · Radiology
Oct 2016
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K162660 is an FDA 510(k) clearance for the Green Smart (Model: PHT-35LHS), 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 October 20, 2016, 24 days after receiving the submission on September 26, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K162660 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2016
Decision Date October 20, 2016
Days to Decision 24 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.