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0909FCC-HS

Model 0909FCC-HS · Rayence Co., Ltd. · DI 08800018602201

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.

36731091452019-01: 0 reports for this device; peer average 4.17/device2019-02: 0 reports for this device; peer average 3.18/device2019-03: 0 reports for this device; peer average 4.29/device2019-04: 0 reports for this device; peer average 7.63/device2019-05: 0 reports for this device; peer average 3/device2019-06: 0 reports for this device; peer average 2.56/device2019-07: 0 reports for this device; peer average 3.57/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 2.43/device2019-10: 0 reports for this device; peer average 2.14/device2019-11: 0 reports for this device; peer average 1.38/device2019-12: 0 reports for this device; peer average 3.09/device2020-01: 0 reports for this device; peer average 1.89/device2020-02: 0 reports for this device; peer average 3.13/device2020-03: 0 reports for this device; peer average 1.33/device2020-04: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 1.67/device2020-06: 0 reports for this device; peer average 2.29/device2020-07: 0 reports for this device; peer average 2.3/device2020-08: 0 reports for this device; peer average 1.4/device2020-09: 0 reports for this device; peer average 2.21/device2020-10: 0 reports for this device; peer average 2.17/device2020-11: 0 reports for this device; peer average 2.12/device2020-12: 0 reports for this device; peer average 2.05/device2021-01: 0 reports for this device; peer average 1.65/device2021-02: 0 reports for this device; peer average 2.42/device2021-03: 0 reports for this device; peer average 2.13/device2021-04: 0 reports for this device; peer average 3.69/device2021-05: 0 reports for this device; peer average 4.2/device2021-06: 0 reports for this device; peer average 5.5/device2021-07: 0 reports for this device; peer average 2.74/device2021-08: 0 reports for this device; peer average 7.61/device2021-09: 0 reports for this device; peer average 9.38/device2021-10: 0 reports for this device; peer average 7.07/device2021-11: 0 reports for this device; peer average 8.55/device2021-12: 0 reports for this device; peer average 6.82/device2022-01: 0 reports for this device; peer average 6.46/device2022-02: 0 reports for this device; peer average 6.38/device2022-03: 0 reports for this device; peer average 7.58/device2022-04: 0 reports for this device; peer average 5.93/device2022-05: 0 reports for this device; peer average 9.34/device2022-06: 0 reports for this device; peer average 6.89/device2022-07: 0 reports for this device; peer average 5.8/device2022-08: 0 reports for this device; peer average 7.65/device2022-09: 0 reports for this device; peer average 7.07/device2022-10: 0 reports for this device; peer average 19.19/device2022-11: 0 reports for this device; peer average 37.58/device2022-12: 0 reports for this device; peer average 35.46/device2023-01: 0 reports for this device; peer average 46.06/device2023-02: 0 reports for this device; peer average 30.42/device2023-03: 0 reports for this device; peer average 50.44/device2023-04: 0 reports for this device; peer average 31.23/device2023-05: 0 reports for this device; peer average 37.94/device2023-06: 0 reports for this device; peer average 29.86/device2023-07: 0 reports for this device; peer average 20.54/device2023-08: 0 reports for this device; peer average 24.8/device2023-09: 0 reports for this device; peer average 37.06/device2023-10: 0 reports for this device; peer average 32.24/device2023-11: 0 reports for this device; peer average 38.64/device2023-12: 0 reports for this device; peer average 42.29/device2024-01: 0 reports for this device; peer average 34.08/device2024-02: 0 reports for this device; peer average 48.73/device2024-03: 0 reports for this device; peer average 30.32/device2024-04: 0 reports for this device; peer average 31.31/device2024-05: 0 reports for this device; peer average 37.59/device2024-06: 0 reports for this device; peer average 30.28/device2024-07: 0 reports for this device; peer average 32.21/device2024-08: 0 reports for this device; peer average 43.12/device2024-09: 0 reports for this device; peer average 46.98/device2024-10: 0 reports for this device; peer average 42.41/device2024-11: 0 reports for this device; peer average 38.5/device2024-12: 0 reports for this device; peer average 41.52/device2025-01: 0 reports for this device; peer average 41.55/device2025-02: 0 reports for this device; peer average 50.94/device2025-03: 0 reports for this device; peer average 38.65/device2025-04: 0 reports for this device; peer average 52.85/device2025-05: 0 reports for this device; peer average 59.74/device2025-06: 0 reports for this device; peer average 55.32/device2025-07: 0 reports for this device; peer average 58.16/device2025-08: 0 reports for this device; peer average 77.17/device2025-09: 0 reports for this device; peer average 145/device2025-10: 0 reports for this device; peer average 123.52/device2025-11: 0 reports for this device; peer average 77.69/device2025-12: 0 reports for this device; peer average 38.28/device2026-01: 0 reports for this device; peer average 37.97/device2026-02: 0 reports for this device; peer average 20.54/device2026-03: 0 reports for this device; peer average 22.82/device2026-04: 0 reports for this device; peer average 19.58/device2026-05: 0 reports for this device; peer average 22.27/device2026-06: 0 reports for this device; peer average 20.18/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.17
2019-0203.18
2019-0304.29
2019-0407.63
2019-0503
2019-0602.56
2019-0703.57
2019-0802
2019-0902.43
2019-1002.14
2019-1101.38
2019-1203.09
2020-0101.89
2020-0203.13
2020-0301.33
2020-0402
2020-0501.67
2020-0602.29
2020-0702.3
2020-0801.4
2020-0902.21
2020-1002.17
2020-1102.12
2020-1202.05
2021-0101.65
2021-0202.42
2021-0302.13
2021-0403.69
2021-0504.2
2021-0605.5
2021-0702.74
2021-0807.61
2021-0909.38
2021-1007.07
2021-1108.55
2021-1206.82
2022-0106.46
2022-0206.38
2022-0307.58
2022-0405.93
2022-0509.34
2022-0606.89
2022-0705.8
2022-0807.65
2022-0907.07
2022-10019.19
2022-11037.58
2022-12035.46
2023-01046.06
2023-02030.42
2023-03050.44
2023-04031.23
2023-05037.94
2023-06029.86
2023-07020.54
2023-08024.8
2023-09037.06
2023-10032.24
2023-11038.64
2023-12042.29
2024-01034.08
2024-02048.73
2024-03030.32
2024-04031.31
2024-05037.59
2024-06030.28
2024-07032.21
2024-08043.12
2024-09046.98
2024-10042.41
2024-11038.5
2024-12041.52
2025-01041.55
2025-02050.94
2025-03038.65
2025-04052.85
2025-05059.74
2025-06055.32
2025-07058.16
2025-08077.17
2025-090145
2025-100123.52
2025-11077.69
2025-12038.28
2026-01037.97
2026-02020.54
2026-03022.82
2026-04019.58
2026-05022.27
2026-06020.18
This device (reports/month)Average device in JAA, MQB (reports/device/month)

Regulatory clearances

  • K240371 SESE 2024-03-07 (k number procode)

Predicate lineage

K240371 — cites (transitively): K212753 (d1), K202722 (d2), K210985 (d2), K162518 (d3), K080859 (d3), K131766 (d3), K171420 (d3), K171461 (d3), K062623 (d4), K113630 (d4), K123345 (d4), K160579 (d4), K122173 (d4), K150150 (d4), K141736 (d4), K153318 (d4), K163210 (d4), K091090 (d5), K101590 (d5), K090625 (d5), K140771 (d5), K945278 (d5), K090742 (d5), K102587 (d5), K031535 (d5), K093355 (d5), K111725 (d5), K131483 (d5), K102078 (d5), K964124 (d6), K090322 (d6), K931071 (d6), K982795 (d6), K063781 (d6) — cited as predicate by K253800

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