510(k) K250976

Airbile-100 by Poskom Co., Ltd. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2025
Date Received
March 31, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type