Cleared Traditional

AirRay

K222896 · Poskom Co., Ltd. · Radiology

Dec 2022

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K222896 is an FDA 510(k) clearance for the AirRay, a System, X-ray, Mobile (Class II — Special Controls, product code IZL), submitted by Poskom Co., Ltd. (Goyang-Si, KR). The FDA issued a Cleared decision on December 20, 2022, 88 days after receiving the submission on September 23, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K222896 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 2022
Decision Date	December 20, 2022
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF