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2D Quantitative Analysis
Model 2D Quantitative Analysis - 1 · Philips Medical Systems Nederland B.V. · DI 00884838075863
LLZ — System, Image Processing, Radiological · Class II · 21 CFR 892.2050
OWB — Interventional Fluoroscopic X-Ray System · Class II · 21 CFR 892.1650
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
7.52
2019-02
0
8.62
2019-03
0
8.84
2019-04
0
10.81
2019-05
0
13.64
2019-06
0
9.47
2019-07
0
10.56
2019-08
0
16.87
2019-09
0
8.53
2019-10
0
7.74
2019-11
0
7.74
2019-12
0
8.61
2020-01
0
5.95
2020-02
0
9.04
2020-03
0
9.62
2020-04
0
12.71
2020-05
0
7.36
2020-06
0
5.48
2020-07
0
5.75
2020-08
0
5.15
2020-09
0
3.78
2020-10
0
5.24
2020-11
0
4.11
2020-12
0
4.5
2021-01
0
4.41
2021-02
0
5.28
2021-03
0
5.17
2021-04
0
6.49
2021-05
0
5.74
2021-06
0
6.45
2021-07
0
4.7
2021-08
0
7.27
2021-09
0
8.67
2021-10
0
6.35
2021-11
0
7.14
2021-12
0
7.35
2022-01
0
6.12
2022-02
0
5.62
2022-03
0
6.94
2022-04
0
6.17
2022-05
0
8.19
2022-06
0
6.65
2022-07
0
6.2
2022-08
0
6.71
2022-09
0
6.85
2022-10
0
20.29
2022-11
0
37.98
2022-12
0
33.87
2023-01
0
45.87
2023-02
0
31.36
2023-03
0
55.22
2023-04
0
32.61
2023-05
0
41.44
2023-06
0
34.17
2023-07
0
23.95
2023-08
0
30.92
2023-09
0
35.49
2023-10
0
34.27
2023-11
0
37.99
2023-12
0
35.77
2024-01
0
36
2024-02
0
51.89
2024-03
0
34.31
2024-04
0
31.5
2024-05
0
30.13
2024-06
0
27.68
2024-07
0
33.17
2024-08
0
39.64
2024-09
0
39.94
2024-10
0
37.75
2024-11
0
34.88
2024-12
0
33.61
2025-01
0
31.39
2025-02
0
45.48
2025-03
0
29.95
2025-04
0
49.03
2025-05
0
44.69
2025-06
0
45.66
2025-07
0
50.22
2025-08
0
76.84
2025-09
0
113.53
2025-10
0
109.08
2025-11
0
76.28
2025-12
0
28.3
2026-01
0
27.99
2026-02
0
22.21
2026-03
0
26.71
2026-04
0
22.29
2026-05
0
26.9
2026-06
0
23.88
This device (reports/month)Average device in LLZ, OWB (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Philips Medical Systems Nederland B.V.
OAI 2025-01-17 Philips Medical Systems Nederland B.V. · 0 citations
OAI 2023-01-26 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 3 citations
NAI 2010-09-21 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · 0 citations