Cleared Traditional

EzRay Air (Model VEX-P300)

K161063 · VATECH Co., Ltd. · Radiology
Sep 2016
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K161063 is an FDA 510(k) clearance for the EzRay Air (Model VEX-P300), a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by VATECH Co., Ltd. (Hwaseong-Si, KR). The FDA issued a Cleared decision on September 1, 2016, 139 days after receiving the submission on April 15, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K161063 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 2016
Decision Date September 01, 2016
Days to Decision 139 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code EHD — Unit, X-ray, Extraoral With Timer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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