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2430TCA
Model 2430TCA · Rayence Co., Ltd. · DI 08800018602256
LLZ — System, Image Processing, Radiological · Class II · 21 CFR 892.2050
MUE — Full Field Digital, System, X-Ray, Mammographic · Class II · 21 CFR 892.1715
UDILibrary device dossier · generated 2026-09-15 · 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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
5
2019-02
0
10.44
2019-03
0
8.71
2019-04
0
7.44
2019-05
0
12.5
2019-06
0
10
2019-07
0
8.63
2019-08
0
18.88
2019-09
0
9.5
2019-10
0
9
2019-11
0
8.43
2019-12
0
11.86
2020-01
0
3.9
2020-02
0
9.08
2020-03
0
9.08
2020-04
0
14.75
2020-05
0
6
2020-06
0
2.6
2020-07
0
3.55
2020-08
0
3.38
2020-09
0
1.88
2020-10
0
3.1
2020-11
0
2.42
2020-12
0
3
2021-01
0
2.83
2021-02
0
3
2021-03
0
3.5
2021-04
0
3.5
2021-05
0
3.73
2021-06
0
3.08
2021-07
0
4.58
2021-08
0
4
2021-09
0
2.33
2021-10
0
3.58
2021-11
0
3.67
2021-12
0
4.5
2022-01
0
3.25
2022-02
0
2.8
2022-03
0
3.67
2022-04
0
2.2
2022-05
0
1.9
2022-06
0
3.64
2022-07
0
2.77
2022-08
0
2.55
2022-09
0
2.75
2022-10
0
3.33
2022-11
0
2.18
2022-12
0
2.13
2023-01
0
2.15
2023-02
0
2.31
2023-03
0
2.5
2023-04
0
2.28
2023-05
0
1.56
2023-06
0
2.71
2023-07
0
2.56
2023-08
0
2.2
2023-09
0
2.1
2023-10
0
3.29
2023-11
0
2.21
2023-12
0
1.87
2024-01
0
2.07
2024-02
0
2.76
2024-03
0
2.59
2024-04
0
4.72
2024-05
0
2.54
2024-06
0
2.46
2024-07
0
3.05
2024-08
0
3.23
2024-09
0
3.23
2024-10
0
3.42
2024-11
0
3.28
2024-12
0
2.21
2025-01
0
6.46
2025-02
0
6.95
2025-03
0
2.59
2025-04
0
2.5
2025-05
0
2.5
2025-06
0
2.89
2025-07
0
3.11
2025-08
0
4.05
2025-09
0
2.85
2025-10
0
9.4
2025-11
0
3.08
2025-12
0
6.56
2026-01
0
7.11
2026-02
0
4.14
2026-03
0
16.03
2026-04
0
11.94
2026-05
0
19.41
2026-06
0
10.38
This device (reports/month)Average device in LLZ, MUE (reports/device/month)