AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)— 510(k) K253244

Substantially Equivalent

Poskom Co., Ltd.

FDA 510(k) clearance K253244 for AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini), Substantially Equivalent on 2026-02-23. Applicant: Poskom Co., Ltd..

Clearance details

Applicant: Poskom Co., Ltd.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2025-09-29
Decision date: 2026-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi-Do, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.