Cleared Special

EzRay Air W

K163705 · VATECH Co., Ltd. · Radiology
Jan 2017
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K163705 is an FDA 510(k) clearance for the EzRay Air W, 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 January 24, 2017, 26 days after receiving the submission on December 29, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K163705 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2016
Decision Date January 24, 2017
Days to Decision 26 days
Submission Type Special
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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