Cleared Traditional

K201627 - Dental Computed Tomography X-Ray System, Green X
(FDA 510(k) Clearance)

K201627 · VATECH Co., Ltd. · Radiology
Oct 2020
Decision
133d
Days
Class 2
Risk

K201627 is an FDA 510(k) clearance for the Dental Computed Tomography X-Ray System, Green X, 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 27, 2020, 133 days after receiving the submission on June 16, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K201627 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2020
Decision Date October 27, 2020
Days to Decision 133 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.