AirRay-20HL
AirRay-20HL 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) K222896 on 20 Dec 2022 and listed in FDA GUDID since 15 Jun 2023 (UDI-DI 08800040900146), 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 | Number08800040900146 | Date15 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222896 | Date20 Dec 2022 | StatusActive |
Official records
- AccessGUDID record 08800040900146
- FDA 510(k) database K222896
Across registries
- FDA 510(k) K222896 decided 20 Dec 2022 Active
- FDA GUDID UDI-DI 08800040900146 listed 15 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K222896
- Listed FDA GUDID 08800040900146
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AirRay
- Generic name
- Diagnostic x-ray system generator, portable
- Model / reference
- AirRay-20HL
- Primary DI / UDI-DI
- 08800040900146
- 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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