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063377717
Model 063377717 · Philips Ultrasound LLC · DI 00884838081239
IYO — System, Imaging, Pulsed Echo, Ultrasonic · Class II · 21 CFR 892.1560
JAK — System, X-Ray, Tomography, Computed · Class II · 21 CFR 892.1750
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
5.15
2019-02
0
7.32
2019-03
0
6.74
2019-04
0
6.17
2019-05
0
8.82
2019-06
0
7.52
2019-07
0
6.54
2019-08
0
13.56
2019-09
0
6.68
2019-10
0
4.61
2019-11
0
5.21
2019-12
0
7.21
2020-01
0
3.2
2020-02
0
6.64
2020-03
0
8.37
2020-04
0
10.19
2020-05
0
3.91
2020-06
0
3.03
2020-07
0
3.69
2020-08
0
2.83
2020-09
0
2.07
2020-10
0
2.9
2020-11
0
3.37
2020-12
0
5.08
2021-01
0
4.96
2021-02
0
3.47
2021-03
0
5.19
2021-04
0
3.85
2021-05
0
5.09
2021-06
0
5.73
2021-07
0
6.61
2021-08
0
5.46
2021-09
0
5.27
2021-10
0
4.12
2021-11
0
4.96
2021-12
0
6.57
2022-01
0
4.6
2022-02
0
4.52
2022-03
0
5
2022-04
0
5.28
2022-05
0
6.65
2022-06
0
4.6
2022-07
0
5
2022-08
0
3.45
2022-09
0
3.38
2022-10
0
3.65
2022-11
0
2.96
2022-12
0
3.08
2023-01
0
3.47
2023-02
0
3.05
2023-03
0
3.86
2023-04
0
2.85
2023-05
0
2.95
2023-06
0
4.79
2023-07
0
3.03
2023-08
0
3.9
2023-09
0
3.41
2023-10
0
5.84
2023-11
0
3.67
2023-12
0
3.33
2024-01
0
4.05
2024-02
0
3.19
2024-03
0
3.47
2024-04
0
4.13
2024-05
0
3
2024-06
0
3.93
2024-07
0
3.47
2024-08
0
3.89
2024-09
0
3.95
2024-10
0
4.29
2024-11
0
2.84
2024-12
0
6.46
2025-01
0
4.61
2025-02
0
4.28
2025-03
0
2.8
2025-04
0
2.71
2025-05
0
2.96
2025-06
0
3.2
2025-07
0
3.16
2025-08
0
4.33
2025-09
0
4.76
2025-10
0
8.19
2025-11
0
7.45
2025-12
0
12.57
2026-01
0
9.91
2026-02
0
4.85
2026-03
0
10.69
2026-04
0
10.28
2026-05
0
14.16
2026-06
0
9.26
This device (reports/month)Average device in IYO, JAK, LLZ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Philips Ultrasound LLC