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20 MHz B-Scan Probe
Model DGH1920 · DGH TECHNOLOGY INC. · DI 00857377006124
ITX — Transducer, Ultrasonic, Diagnostic · Class II · 21 CFR 892.1570
IYO — System, Imaging, Pulsed Echo, Ultrasonic · Class II · 21 CFR 892.1560
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
3.5
2019-02
0
6.03
2019-03
0
6.61
2019-04
0
4.04
2019-05
0
6.29
2019-06
0
6.61
2019-07
0
6.15
2019-08
0
8.83
2019-09
0
4.33
2019-10
0
3.77
2019-11
0
4.12
2019-12
0
5.4
2020-01
0
2.83
2020-02
0
5.33
2020-03
0
6.39
2020-04
0
5.93
2020-05
0
3.07
2020-06
0
3.29
2020-07
0
4.37
2020-08
0
2.98
2020-09
0
2.09
2020-10
0
3.75
2020-11
0
3.98
2020-12
0
5.64
2021-01
0
6.19
2021-02
0
4.44
2021-03
0
6.82
2021-04
0
4.18
2021-05
0
5.62
2021-06
0
6.19
2021-07
0
7.78
2021-08
0
6.9
2021-09
0
8.44
2021-10
0
5.82
2021-11
0
6.22
2021-12
0
9.2
2022-01
0
6.28
2022-02
0
8.02
2022-03
0
6.86
2022-04
0
7.34
2022-05
0
8.62
2022-06
0
6.86
2022-07
0
6.56
2022-08
0
5.32
2022-09
0
4.54
2022-10
0
4.4
2022-11
0
4.2
2022-12
0
4.93
2023-01
0
5
2023-02
0
4.41
2023-03
0
5.37
2023-04
0
3.59
2023-05
0
5.44
2023-06
0
3.91
2023-07
0
4.06
2023-08
0
5.41
2023-09
0
5.34
2023-10
0
6.63
2023-11
0
4.98
2023-12
0
5.11
2024-01
0
6.22
2024-02
0
4.33
2024-03
0
5.51
2024-04
0
5.53
2024-05
0
4.07
2024-06
0
5.6
2024-07
0
4.82
2024-08
0
5.39
2024-09
0
5.41
2024-10
0
6.1
2024-11
0
3.74
2024-12
0
10.49
2025-01
0
4.21
2025-02
0
3.87
2025-03
0
5.42
2025-04
0
3.21
2025-05
0
3.91
2025-06
0
4.08
2025-07
0
4
2025-08
0
5.65
2025-09
0
6.9
2025-10
0
9.3
2025-11
0
11.99
2025-12
0
17.98
2026-01
0
11.73
2026-02
0
6.45
2026-03
0
8.52
2026-04
0
11.37
2026-05
0
15.8
2026-06
0
14.56
This device (reports/month)Average device in ITX, IYO (reports/device/month)