Cleared Traditional

PaX-i3D Green Premium (Model: PCT-90LH)

K160882 · VATECH Co., Ltd. · Radiology

Oct 2016

Decision

211d

Days

Class 2

Risk

About This 510(k) Submission

K160882 is an FDA 510(k) clearance for the PaX-i3D Green Premium (Model: PCT-90LH), 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 28, 2016, 211 days after receiving the submission on March 31, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number	K160882 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2016
Decision Date	October 28, 2016
Days to Decision	211 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.