Cleared Special

EzRay Air 2 Wall (Model: VEX-S350W)

K223058 · VATECH Co., Ltd. · Radiology
Oct 2022
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K223058 is an FDA 510(k) clearance for the EzRay Air 2 Wall (Model: VEX-S350W), 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 October 26, 2022, 26 days after receiving the submission on September 30, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K223058 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2022
Decision Date October 26, 2022
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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