AirRay
Model AirRay-20HW · Poskom Co., Ltd. · DI 08800040900153
IZL — System, X-Ray, Mobile · Class II · 21 CFR 892.1720
UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-03 | 0 | 2 |
| 2019-04 | 0 | 3.5 |
| 2019-07 | 0 | 1 |
| 2019-09 | 0 | 1.5 |
| 2019-12 | 0 | 1 |
| 2020-01 | 0 | 1.5 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 1 |
| 2020-04 | 0 | 1.67 |
| 2020-06 | 0 | 2 |
| 2020-08 | 0 | 1.67 |
| 2020-10 | 0 | 2.5 |
| 2020-12 | 0 | 2.36 |
| 2021-01 | 0 | 2.67 |
| 2021-02 | 0 | 1.5 |
| 2021-03 | 0 | 2 |
| 2021-04 | 0 | 2 |
| 2021-05 | 0 | 1.29 |
| 2021-06 | 0 | 1 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 1.5 |
| 2021-09 | 0 | 1 |
| 2021-10 | 0 | 2 |
| 2021-12 | 0 | 1 |
| 2022-02 | 0 | 3 |
| 2022-03 | 0 | 2 |
| 2022-04 | 0 | 1.33 |
| 2022-05 | 0 | 1.57 |
| 2022-06 | 0 | 1.38 |
| 2022-07 | 0 | 6 |
| 2022-09 | 0 | 1 |
| 2022-11 | 0 | 3.5 |
| 2022-12 | 0 | 2 |
| 2023-01 | 0 | 2 |
| 2023-02 | 0 | 1.5 |
| 2023-03 | 0 | 3 |
| 2023-04 | 0 | 1.45 |
| 2023-05 | 0 | 2 |
| 2023-06 | 0 | 4.5 |
| 2023-07 | 0 | 3 |
| 2023-09 | 0 | 3 |
| 2023-10 | 0 | 2 |
| 2023-11 | 0 | 3 |
| 2023-12 | 0 | 2.5 |
| 2024-03 | 0 | 2 |
| 2024-04 | 0 | 1 |
| 2024-05 | 0 | 2 |
| 2024-06 | 0 | 1 |
| 2024-07 | 0 | 1.25 |
| 2024-08 | 0 | 1 |
| 2025-01 | 0 | 1 |
| 2025-03 | 0 | 2 |
| 2025-04 | 0 | 1 |
| 2025-05 | 0 | 1 |
| 2025-07 | 0 | 1 |
| 2025-10 | 0 | 1 |
| 2025-11 | 0 | 1.33 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 1 |
| 2026-05 | 0 | 1.33 |
| 2026-06 | 0 | 1 |
Regulatory clearances
- K222896 SESE 2022-12-20 (k number procode)
Predicate lineage
K222896 — cites (transitively): K182207 (d1), K153059 (d2), K945707 (d2), K040046 (d3), K130883 (d3), K131211 (d3), K143257 (d3), K083645 (d4), K091364 (d4), K090238 (d4), K091436 (d4), K103591 (d4), K111682 (d4), K130337 (d4), K130377 (d4), K131121 (d4), K133782 (d4), K140551 (d4), K140825 (d4), K080582 (d5), K093831 (d5), K090279 (d5), K122495 (d5), K043437 (d6), K042876 (d6), K063283 (d6) — cited as predicate by K230581
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Poskom Co., Ltd.
Nothing in the loaded window.