AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
FDA 510(k) K253244 · Poskom Co., Ltd.
510(k) numberK253244
Submission
- Device name
- AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)
- Applicant
- Poskom Co., Ltd.
Gyeonggi-Do, KR - Received
- September 29, 2025
- Decision date
- February 23, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K251223 | HnX-P1, HnX-PBIZL · Traditional | H&abyz Co., Ltd. | 08/04/2025SE |
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Questions and answers
When was AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) cleared by the FDA?
AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) (K253244) received a 510(k) decision of Substantially Equivalent on February 23, 2026, 147 days after the submission was received.
What is the product code of K253244?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.