Print-ready dossier — use your browser's print dialog to save as PDF.
"MyLabSeven LCD 19"""
Model 101640001 · ESAOTE SPA · DI 08056304450340
ITX — Transducer, Ultrasonic, Diagnostic · Class II · 21 CFR 892.1570
IYN — System, Imaging, Pulsed Doppler, Ultrasonic · Class II · 21 CFR 892.1550
IYO — System, Imaging, Pulsed Echo, Ultrasonic · Class II · 21 CFR 892.1560
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.
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
3.15
2019-02
0
5.46
2019-03
0
5.81
2019-04
0
3.3
2019-05
0
5.27
2019-06
0
6.28
2019-07
0
5.59
2019-08
0
7.45
2019-09
0
3.92
2019-10
0
3.57
2019-11
0
4.04
2019-12
0
4.84
2020-01
0
2.75
2020-02
0
5.41
2020-03
0
5.5
2020-04
0
5.17
2020-05
0
2.89
2020-06
0
3.16
2020-07
0
4.32
2020-08
0
2.93
2020-09
0
2.07
2020-10
0
3.79
2020-11
0
4.01
2020-12
0
5.87
2021-01
0
6.53
2021-02
0
4.61
2021-03
0
7.44
2021-04
0
4.17
2021-05
0
5.98
2021-06
0
6.44
2021-07
0
8.34
2021-08
0
7.22
2021-09
0
9.35
2021-10
0
5.7
2021-11
0
6.88
2021-12
0
9.64
2022-01
0
6.49
2022-02
0
8.37
2022-03
0
7.24
2022-04
0
8.11
2022-05
0
9.67
2022-06
0
7.56
2022-07
0
7.46
2022-08
0
5.42
2022-09
0
4.73
2022-10
0
4.62
2022-11
0
4.41
2022-12
0
5.16
2023-01
0
5.01
2023-02
0
4.61
2023-03
0
5.75
2023-04
0
3.78
2023-05
0
6.15
2023-06
0
4.06
2023-07
0
4.25
2023-08
0
5.94
2023-09
0
5.7
2023-10
0
6.69
2023-11
0
5.36
2023-12
0
5.47
2024-01
0
6.28
2024-02
0
4.31
2024-03
0
5.97
2024-04
0
5.86
2024-05
0
4.16
2024-06
0
5.85
2024-07
0
4.97
2024-08
0
5.4
2024-09
0
5.79
2024-10
0
6.4
2024-11
0
4.03
2024-12
0
11.27
2025-01
0
4.34
2025-02
0
4.03
2025-03
0
5.83
2025-04
0
3.25
2025-05
0
3.93
2025-06
0
4.11
2025-07
0
4.1
2025-08
0
5.45
2025-09
0
6.52
2025-10
0
9.71
2025-11
0
12.53
2025-12
0
18.81
2026-01
0
11.99
2026-02
0
6.63
2026-03
0
8.63
2026-04
0
11.88
2026-05
0
16.78
2026-06
0
15.26
This device (reports/month)Average device in ITX, IYN, IYO (reports/device/month)