Cleared Traditional

Airbile-100

K250976 · Poskom Co., Ltd. · Radiology

Dec 2025

Decision

263d

Days

Class 2

Risk

About This 510(k) Submission

K250976 is an FDA 510(k) clearance for the Airbile-100, 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 December 19, 2025, 263 days after receiving the submission on March 31, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K250976 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2025
Decision Date	December 19, 2025
Days to Decision	263 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF