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Airbile-100

by Poskom Co., Ltd.

Airbile-100 is a diagnostic x-ray system generator (FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by Poskom Co., Ltd., cleared under FDA 510(k) K250976 on 19 Dec 2025 and listed in FDA GUDID since 15 Apr 2026 (UDI-DI 08800040900221), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K250976

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800040900221 UDI-DI Date15 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK250976 Date19 Dec 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K250976 decided 19 Dec 2025 Active
  • FDA GUDID UDI-DI 08800040900221 listed 15 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K250976
  2. Listed FDA GUDID 08800040900221

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Diagnostic x-ray system generator, portable
Model / reference
Airbile-100
Primary DI / UDI-DI
08800040900221
510(k) Number
FDA product code
IZL
GMDN term
Diagnostic x-ray system generator, portable
Device class
Class II
Regulation number
892.1720
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code IZL (System, X-Ray, Mobile).

Other devices from Poskom Co., Ltd.

See all devices from Poskom Co., Ltd. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)