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3D-RA

Model 3D-RA - 6 · Philips Medical Systems Nederland B.V. · DI 00884838084766

JAK — System, X-Ray, Tomography, Computed · Class II · 21 CFR 892.1750

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 2026-09-15 · 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.

254974982019-01: 0 reports for this device; peer average 6.74/device2019-02: 0 reports for this device; peer average 6.9/device2019-03: 0 reports for this device; peer average 6.68/device2019-04: 0 reports for this device; peer average 8.56/device2019-05: 0 reports for this device; peer average 8.85/device2019-06: 0 reports for this device; peer average 7.17/device2019-07: 0 reports for this device; peer average 7.14/device2019-08: 0 reports for this device; peer average 12.27/device2019-09: 0 reports for this device; peer average 6.67/device2019-10: 0 reports for this device; peer average 5.61/device2019-11: 0 reports for this device; peer average 6.15/device2019-12: 0 reports for this device; peer average 7.32/device2020-01: 0 reports for this device; peer average 4.59/device2020-02: 0 reports for this device; peer average 6.89/device2020-03: 0 reports for this device; peer average 8.19/device2020-04: 0 reports for this device; peer average 11.12/device2020-05: 0 reports for this device; peer average 5.26/device2020-06: 0 reports for this device; peer average 4.63/device2020-07: 0 reports for this device; peer average 4.29/device2020-08: 0 reports for this device; peer average 3.71/device2020-09: 0 reports for this device; peer average 3.14/device2020-10: 0 reports for this device; peer average 3.96/device2020-11: 0 reports for this device; peer average 3.51/device2020-12: 0 reports for this device; peer average 3.86/device2021-01: 0 reports for this device; peer average 3.48/device2021-02: 0 reports for this device; peer average 4/device2021-03: 0 reports for this device; peer average 4.16/device2021-04: 0 reports for this device; peer average 4.85/device2021-05: 0 reports for this device; peer average 4.98/device2021-06: 0 reports for this device; peer average 5.75/device2021-07: 0 reports for this device; peer average 4.23/device2021-08: 0 reports for this device; peer average 5.94/device2021-09: 0 reports for this device; peer average 6.69/device2021-10: 0 reports for this device; peer average 5.3/device2021-11: 0 reports for this device; peer average 5.82/device2021-12: 0 reports for this device; peer average 5.89/device2022-01: 0 reports for this device; peer average 4.85/device2022-02: 0 reports for this device; peer average 4.79/device2022-03: 0 reports for this device; peer average 5.61/device2022-04: 0 reports for this device; peer average 5.1/device2022-05: 0 reports for this device; peer average 7.18/device2022-06: 0 reports for this device; peer average 5.01/device2022-07: 0 reports for this device; peer average 5.46/device2022-08: 0 reports for this device; peer average 5.26/device2022-09: 0 reports for this device; peer average 5.44/device2022-10: 0 reports for this device; peer average 17.06/device2022-11: 0 reports for this device; peer average 31/device2022-12: 0 reports for this device; peer average 27.35/device2023-01: 0 reports for this device; peer average 37.29/device2023-02: 0 reports for this device; peer average 23.29/device2023-03: 0 reports for this device; peer average 44.83/device2023-04: 0 reports for this device; peer average 27.6/device2023-05: 0 reports for this device; peer average 32.13/device2023-06: 0 reports for this device; peer average 26.04/device2023-07: 0 reports for this device; peer average 18.81/device2023-08: 0 reports for this device; peer average 21.75/device2023-09: 0 reports for this device; peer average 28.29/device2023-10: 0 reports for this device; peer average 27.89/device2023-11: 0 reports for this device; peer average 30.51/device2023-12: 0 reports for this device; peer average 28.19/device2024-01: 0 reports for this device; peer average 31.2/device2024-02: 0 reports for this device; peer average 42.01/device2024-03: 0 reports for this device; peer average 27.23/device2024-04: 0 reports for this device; peer average 25.39/device2024-05: 0 reports for this device; peer average 24.7/device2024-06: 0 reports for this device; peer average 24.04/device2024-07: 0 reports for this device; peer average 27.28/device2024-08: 0 reports for this device; peer average 34.59/device2024-09: 0 reports for this device; peer average 34.34/device2024-10: 0 reports for this device; peer average 30/device2024-11: 0 reports for this device; peer average 27.77/device2024-12: 0 reports for this device; peer average 28.67/device2025-01: 0 reports for this device; peer average 26.52/device2025-02: 0 reports for this device; peer average 37.34/device2025-03: 0 reports for this device; peer average 23.81/device2025-04: 0 reports for this device; peer average 41.17/device2025-05: 0 reports for this device; peer average 40.57/device2025-06: 0 reports for this device; peer average 39.81/device2025-07: 0 reports for this device; peer average 41.93/device2025-08: 0 reports for this device; peer average 62.1/device2025-09: 0 reports for this device; peer average 98.45/device2025-10: 0 reports for this device; peer average 96.94/device2025-11: 0 reports for this device; peer average 63/device2025-12: 0 reports for this device; peer average 23.76/device2026-01: 0 reports for this device; peer average 25.19/device2026-02: 0 reports for this device; peer average 18.06/device2026-03: 0 reports for this device; peer average 23.52/device2026-04: 0 reports for this device; peer average 18.46/device2026-05: 0 reports for this device; peer average 22.25/device2026-06: 0 reports for this device; peer average 17.53/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0106.74
2019-0206.9
2019-0306.68
2019-0408.56
2019-0508.85
2019-0607.17
2019-0707.14
2019-08012.27
2019-0906.67
2019-1005.61
2019-1106.15
2019-1207.32
2020-0104.59
2020-0206.89
2020-0308.19
2020-04011.12
2020-0505.26
2020-0604.63
2020-0704.29
2020-0803.71
2020-0903.14
2020-1003.96
2020-1103.51
2020-1203.86
2021-0103.48
2021-0204
2021-0304.16
2021-0404.85
2021-0504.98
2021-0605.75
2021-0704.23
2021-0805.94
2021-0906.69
2021-1005.3
2021-1105.82
2021-1205.89
2022-0104.85
2022-0204.79
2022-0305.61
2022-0405.1
2022-0507.18
2022-0605.01
2022-0705.46
2022-0805.26
2022-0905.44
2022-10017.06
2022-11031
2022-12027.35
2023-01037.29
2023-02023.29
2023-03044.83
2023-04027.6
2023-05032.13
2023-06026.04
2023-07018.81
2023-08021.75
2023-09028.29
2023-10027.89
2023-11030.51
2023-12028.19
2024-01031.2
2024-02042.01
2024-03027.23
2024-04025.39
2024-05024.7
2024-06024.04
2024-07027.28
2024-08034.59
2024-09034.34
2024-10030
2024-11027.77
2024-12028.67
2025-01026.52
2025-02037.34
2025-03023.81
2025-04041.17
2025-05040.57
2025-06039.81
2025-07041.93
2025-08062.1
2025-09098.45
2025-10096.94
2025-11063
2025-12023.76
2026-01025.19
2026-02018.06
2026-03023.52
2026-04018.46
2026-05022.25
2026-06017.53
This device (reports/month)Average device in JAK, 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