Cleared Special

K200182 - EzRay Air Portable (Model: VEX-P300)
(FDA 510(k) Clearance)

K200182 · VATECH Co., Ltd. · Radiology

Feb 2020

Decision

18d

Days

Class 2

Risk

K200182 is an FDA 510(k) clearance for the EzRay Air Portable (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 February 11, 2020, 18 days after receiving the submission on January 24, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K200182 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 24, 2020
Decision Date	February 11, 2020
Days to Decision	18 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF