0909FCB
Model 0909FCB · Rayence Co., Ltd. · DI 08800018600900
JAA — System, X-Ray, Fluoroscopic, Image-Intensified · Class II · 21 CFR 892.1650
MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager) · Class II · 21 CFR 892.1680
UDILibrary device dossier · generated 2026-09-13 · 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 | 4.17 |
| 2019-02 | 0 | 3.18 |
| 2019-03 | 0 | 4.29 |
| 2019-04 | 0 | 7.63 |
| 2019-05 | 0 | 3 |
| 2019-06 | 0 | 2.56 |
| 2019-07 | 0 | 3.57 |
| 2019-08 | 0 | 2 |
| 2019-09 | 0 | 2.43 |
| 2019-10 | 0 | 2.14 |
| 2019-11 | 0 | 1.38 |
| 2019-12 | 0 | 3.09 |
| 2020-01 | 0 | 1.89 |
| 2020-02 | 0 | 3.13 |
| 2020-03 | 0 | 1.33 |
| 2020-04 | 0 | 2 |
| 2020-05 | 0 | 1.67 |
| 2020-06 | 0 | 2.29 |
| 2020-07 | 0 | 2.3 |
| 2020-08 | 0 | 1.4 |
| 2020-09 | 0 | 2.21 |
| 2020-10 | 0 | 2.17 |
| 2020-11 | 0 | 2.12 |
| 2020-12 | 0 | 2.05 |
| 2021-01 | 0 | 1.65 |
| 2021-02 | 0 | 2.42 |
| 2021-03 | 0 | 2.13 |
| 2021-04 | 0 | 3.69 |
| 2021-05 | 0 | 4.2 |
| 2021-06 | 0 | 5.5 |
| 2021-07 | 0 | 2.74 |
| 2021-08 | 0 | 7.61 |
| 2021-09 | 0 | 9.38 |
| 2021-10 | 0 | 7.07 |
| 2021-11 | 0 | 8.55 |
| 2021-12 | 0 | 6.82 |
| 2022-01 | 0 | 6.46 |
| 2022-02 | 0 | 6.38 |
| 2022-03 | 0 | 7.58 |
| 2022-04 | 0 | 5.93 |
| 2022-05 | 0 | 9.34 |
| 2022-06 | 0 | 6.89 |
| 2022-07 | 0 | 5.8 |
| 2022-08 | 0 | 7.65 |
| 2022-09 | 0 | 7.07 |
| 2022-10 | 0 | 19.19 |
| 2022-11 | 0 | 37.58 |
| 2022-12 | 0 | 35.46 |
| 2023-01 | 0 | 46.06 |
| 2023-02 | 0 | 30.42 |
| 2023-03 | 0 | 50.44 |
| 2023-04 | 0 | 31.23 |
| 2023-05 | 0 | 37.94 |
| 2023-06 | 0 | 29.86 |
| 2023-07 | 0 | 20.54 |
| 2023-08 | 0 | 24.8 |
| 2023-09 | 0 | 37.06 |
| 2023-10 | 0 | 32.24 |
| 2023-11 | 0 | 38.64 |
| 2023-12 | 0 | 42.29 |
| 2024-01 | 0 | 34.08 |
| 2024-02 | 0 | 48.73 |
| 2024-03 | 0 | 30.32 |
| 2024-04 | 0 | 31.31 |
| 2024-05 | 0 | 37.59 |
| 2024-06 | 0 | 30.28 |
| 2024-07 | 0 | 32.21 |
| 2024-08 | 0 | 43.12 |
| 2024-09 | 0 | 46.98 |
| 2024-10 | 0 | 42.41 |
| 2024-11 | 0 | 38.5 |
| 2024-12 | 0 | 41.52 |
| 2025-01 | 0 | 41.55 |
| 2025-02 | 0 | 50.94 |
| 2025-03 | 0 | 38.65 |
| 2025-04 | 0 | 52.85 |
| 2025-05 | 0 | 59.74 |
| 2025-06 | 0 | 55.32 |
| 2025-07 | 0 | 58.16 |
| 2025-08 | 0 | 77.17 |
| 2025-09 | 0 | 145 |
| 2025-10 | 0 | 123.52 |
| 2025-11 | 0 | 77.69 |
| 2025-12 | 0 | 38.28 |
| 2026-01 | 0 | 37.97 |
| 2026-02 | 0 | 20.54 |
| 2026-03 | 0 | 22.82 |
| 2026-04 | 0 | 19.58 |
| 2026-05 | 0 | 22.27 |
| 2026-06 | 0 | 20.18 |
Regulatory clearances
- K212753 SESE 2021-10-18 (k number procode)
Predicate lineage
K212753 — cites (transitively): K202722 (d1), K210985 (d1), K162518 (d2), K080859 (d2), K131766 (d2), K171420 (d2), K171461 (d2), K062623 (d3), K113630 (d3), K123345 (d3), K160579 (d3), K122173 (d3), K150150 (d3), K141736 (d3), K153318 (d3), K163210 (d3), K091090 (d4), K101590 (d4), K090625 (d4), K140771 (d4), K945278 (d4), K090742 (d4), K102587 (d4), K031535 (d4), K093355 (d4), K111725 (d4), K131483 (d4), K102078 (d4), K964124 (d5), K090322 (d5), K931071 (d5), K982795 (d5), K063781 (d5) — cited as predicate by K240371
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Rayence Co., Ltd.
- NAI 2013-07-16 Rayence Co. Ltd. · 0 citations
- NAI 2013-07-16 Rayence Co. Ltd. · 0 citations