Cleared Traditional

Green16/Green18 (Model: PHT-65LHS)

K170066 · VATECH Co., Ltd. · Radiology
Jun 2017
Decision
158d
Days
Class 2
Risk

About This 510(k) Submission

K170066 is an FDA 510(k) clearance for the Green16/Green18 (Model: PHT-65LHS), 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 June 16, 2017, 158 days after receiving the submission on January 9, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K170066 FDA.gov
FDA Decision Cleared SESE
Date Received January 09, 2017
Decision Date June 16, 2017
Days to Decision 158 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.