AirRay-mini 80A
AirRay-mini 80A 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) K253244 on 23 Feb 2026 and listed in FDA GUDID since 15 Apr 2026 (UDI-DI 08800040900245), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08800040900245 | Date15 Apr 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK253244 | Date23 Feb 2026 | StatusActive |
Official records
- AccessGUDID record 08800040900245
- FDA 510(k) database K253244
Across registries
- FDA 510(k) K253244 decided 23 Feb 2026 Active
- FDA GUDID UDI-DI 08800040900245 listed 15 Apr 2026 Listed
Timeline
- Cleared FDA 510(k) K253244
- Listed FDA GUDID 08800040900245
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AirRay-mini
- Generic name
- Diagnostic x-ray system generator, portable
- Model / reference
- AirRay-mini 80A
- Primary DI / UDI-DI
- 08800040900245
- 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
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