K253244
- 510(k) number
- K253244
- Device name
- AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
- Applicant
- Poskom Co., Ltd. KR
- Product code
- IZL — System, X-Ray, Mobile
- Decision date
- 2026-02-23
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253244.pdf
Official FDA record: K253244
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.