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EXTRON 3
Model EXTRON 3 · DRTECH Corporation · DI 08800018422601
JAA — System, X-Ray, Fluoroscopic, Image-Intensified · Class II · 21 CFR 892.1650
OWB — Interventional Fluoroscopic X-Ray System · Class II · 21 CFR 892.1650
OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile · Class II · 21 CFR 892.1650
UDILibrary device dossier · generated 2026-09-12 · 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
11.14
2019-02
0
6.96
2019-03
0
9
2019-04
0
12.39
2019-05
0
11.21
2019-06
0
8.12
2019-07
0
9.87
2019-08
0
10.86
2019-09
0
7.18
2019-10
0
7.03
2019-11
0
6.75
2019-12
0
7.21
2020-01
0
7.14
2020-02
0
8.11
2020-03
0
9.94
2020-04
0
9
2020-05
0
8.87
2020-06
0
7.54
2020-07
0
7.32
2020-08
0
7
2020-09
0
5.97
2020-10
0
6.37
2020-11
0
5.02
2020-12
0
4.96
2021-01
0
5.22
2021-02
0
6.05
2021-03
0
5.96
2021-04
0
7.74
2021-05
0
7.04
2021-06
0
8.24
2021-07
0
4.61
2021-08
0
8.76
2021-09
0
9.57
2021-10
0
7.32
2021-11
0
8.45
2021-12
0
7.84
2022-01
0
6.8
2022-02
0
6.7
2022-03
0
7.88
2022-04
0
7.41
2022-05
0
9.84
2022-06
0
7.29
2022-07
0
6.78
2022-08
0
7.57
2022-09
0
7.46
2022-10
0
20.57
2022-11
0
38.1
2022-12
0
36.69
2023-01
0
47.93
2023-02
0
32.99
2023-03
0
57.63
2023-04
0
37.39
2023-05
0
43.25
2023-06
0
35.89
2023-07
0
25.98
2023-08
0
29.28
2023-09
0
40.35
2023-10
0
35.02
2023-11
0
40.46
2023-12
0
43.76
2024-01
0
38.19
2024-02
0
57.14
2024-03
0
37.49
2024-04
0
35.77
2024-05
0
37.21
2024-06
0
33.37
2024-07
0
36.1
2024-08
0
46.64
2024-09
0
47.79
2024-10
0
41.04
2024-11
0
38.81
2024-12
0
39.34
2025-01
0
39
2025-02
0
51.09
2025-03
0
42.53
2025-04
0
54.92
2025-05
0
60.56
2025-06
0
56.7
2025-07
0
64.05
2025-08
0
86.5
2025-09
0
152.33
2025-10
0
137.96
2025-11
0
93.77
2025-12
0
40.6
2026-01
0
36.26
2026-02
0
27.67
2026-03
0
28.75
2026-04
0
26.01
2026-05
0
27.96
2026-06
0
24.75
This device (reports/month)Average device in JAA, OWB, OXO (reports/device/month)