Cleared Traditional

AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)

K253244 · Poskom Co., Ltd. · Radiology

Feb 2026

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K253244 is an FDA 510(k) clearance for the AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini), a System, X-ray, Mobile (Class II — Special Controls, product code IZL), submitted by Poskom Co., Ltd. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on February 23, 2026, 147 days after receiving the submission on September 29, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K253244 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2025
Decision Date	February 23, 2026
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF