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3-matic
Model 3-matic Medical · Materialise NV · DI E3143MATICMEDICAL0
LLZ — System, Image Processing, Radiological · Class II · 21 CFR 892.2050
UDILibrary device dossier · generated 2026-09-07 · 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
11.5
2019-03
0
8.71
2019-04
0
7.44
2019-05
0
15.67
2019-06
0
11
2019-07
0
12.6
2019-08
0
24.67
2019-09
0
9.5
2019-10
0
9
2019-11
0
9.5
2019-12
0
13.67
2020-01
0
4.38
2020-02
0
10.4
2020-03
0
9.75
2020-04
0
14.75
2020-05
0
6
2020-06
0
2.6
2020-07
0
3.6
2020-08
0
3.38
2020-09
0
1.87
2020-10
0
3.22
2020-11
0
2.36
2020-12
0
3.4
2021-01
0
2.91
2021-02
0
3
2021-03
0
3.5
2021-04
0
3.5
2021-05
0
4
2021-06
0
3.08
2021-07
0
4.58
2021-08
0
4
2021-09
0
2.5
2021-10
0
3.58
2021-11
0
3.45
2021-12
0
4.5
2022-01
0
3.29
2022-02
0
2.8
2022-03
0
3.67
2022-04
0
2.15
2022-05
0
1.78
2022-06
0
4
2022-07
0
2.83
2022-08
0
2.7
2022-09
0
2.75
2022-10
0
3.33
2022-11
0
2.18
2022-12
0
2.13
2023-01
0
2.27
2023-02
0
2.42
2023-03
0
2.47
2023-04
0
2.28
2023-05
0
1.56
2023-06
0
2.85
2023-07
0
2.75
2023-08
0
2.11
2023-09
0
2.05
2023-10
0
3.58
2023-11
0
2.22
2023-12
0
1.91
2024-01
0
2.07
2024-02
0
2.76
2024-03
0
2.75
2024-04
0
4.72
2024-05
0
2.61
2024-06
0
2.58
2024-07
0
3.05
2024-08
0
3.33
2024-09
0
3.33
2024-10
0
3.42
2024-11
0
3.28
2024-12
0
2.28
2025-01
0
6.46
2025-02
0
6.95
2025-03
0
2.59
2025-04
0
2.5
2025-05
0
2.48
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
4.38
2026-03
0
16.38
2026-04
0
12.28
2026-05
0
19.41
2026-06
0
10.38
This device (reports/month)Average device in LLZ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K060950 — cited as predicate by K120956, K222195
Lineage extracted from public 510(k) summary text (heuristic).