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Lumify Diagnostic Ultrasound System

Model 795123 · Philips Ultrasound LLC · DI 00884838113947

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 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (3)

InitiatedRecall #ClassStatusReasonLink basis
2025-10-31Z-0883-2026Class IIOpen, ClassifiedUltrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.k number procode
2025-07-03Z-2374-2025Class IIIOpen, ClassifiedTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.k number procode
2025-07-03Z-2392-2025Class IIIOpen, ClassifiedTo provide clarification and labelling to define the useful life of ultrasound transducers in the field.k number procode

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.

5914192019-01: 0 reports for this device; peer average 3.15/device2019-02: 0 reports for this device; peer average 5.46/device2019-03: 0 reports for this device; peer average 5.81/device2019-04: 0 reports for this device; peer average 3.3/device2019-05: 0 reports for this device; peer average 5.27/device2019-06: 0 reports for this device; peer average 6.28/device2019-07: 0 reports for this device; peer average 5.59/device2019-08: 0 reports for this device; peer average 7.45/device2019-09: 0 reports for this device; peer average 3.92/device2019-10: 0 reports for this device; peer average 3.57/device2019-11: 0 reports for this device; peer average 4.04/device2019-12: 0 reports for this device; peer average 4.84/device2020-01: 0 reports for this device; peer average 2.75/device2020-02: 0 reports for this device; peer average 5.41/device2020-03: 0 reports for this device; peer average 5.5/device2020-04: 0 reports for this device; peer average 5.17/device2020-05: 0 reports for this device; peer average 2.89/device2020-06: 0 reports for this device; peer average 3.16/device2020-07: 0 reports for this device; peer average 4.32/device2020-08: 0 reports for this device; peer average 2.93/device2020-09: 0 reports for this device; peer average 2.07/device2020-10: 0 reports for this device; peer average 3.79/device2020-11: 0 reports for this device; peer average 4.01/device2020-12: 0 reports for this device; peer average 5.87/device2021-01: 0 reports for this device; peer average 6.53/device2021-02: 0 reports for this device; peer average 4.61/device2021-03: 0 reports for this device; peer average 7.44/device2021-04: 0 reports for this device; peer average 4.17/device2021-05: 0 reports for this device; peer average 5.98/device2021-06: 0 reports for this device; peer average 6.44/device2021-07: 0 reports for this device; peer average 8.34/device2021-08: 0 reports for this device; peer average 7.22/device2021-09: 0 reports for this device; peer average 9.35/device2021-10: 0 reports for this device; peer average 5.7/device2021-11: 0 reports for this device; peer average 6.88/device2021-12: 0 reports for this device; peer average 9.64/device2022-01: 0 reports for this device; peer average 6.49/device2022-02: 0 reports for this device; peer average 8.37/device2022-03: 0 reports for this device; peer average 7.24/device2022-04: 0 reports for this device; peer average 8.11/device2022-05: 0 reports for this device; peer average 9.67/device2022-06: 0 reports for this device; peer average 7.56/device2022-07: 0 reports for this device; peer average 7.46/device2022-08: 0 reports for this device; peer average 5.42/device2022-09: 0 reports for this device; peer average 4.73/device2022-10: 0 reports for this device; peer average 4.62/device2022-11: 0 reports for this device; peer average 4.41/device2022-12: 0 reports for this device; peer average 5.16/device2023-01: 0 reports for this device; peer average 5.01/device2023-02: 0 reports for this device; peer average 4.61/device2023-03: 0 reports for this device; peer average 5.75/device2023-04: 0 reports for this device; peer average 3.78/device2023-05: 0 reports for this device; peer average 6.15/device2023-06: 0 reports for this device; peer average 4.06/device2023-07: 0 reports for this device; peer average 4.25/device2023-08: 0 reports for this device; peer average 5.94/device2023-09: 0 reports for this device; peer average 5.7/device2023-10: 0 reports for this device; peer average 6.69/device2023-11: 0 reports for this device; peer average 5.36/device2023-12: 0 reports for this device; peer average 5.47/device2024-01: 0 reports for this device; peer average 6.28/device2024-02: 0 reports for this device; peer average 4.31/device2024-03: 0 reports for this device; peer average 5.97/device2024-04: 0 reports for this device; peer average 5.86/device2024-05: 0 reports for this device; peer average 4.16/device2024-06: 0 reports for this device; peer average 5.85/device2024-07: 0 reports for this device; peer average 4.97/device2024-08: 0 reports for this device; peer average 5.4/device2024-09: 0 reports for this device; peer average 5.79/device2024-10: 0 reports for this device; peer average 6.4/device2024-11: 0 reports for this device; peer average 4.03/device2024-12: 0 reports for this device; peer average 11.27/device2025-01: 0 reports for this device; peer average 4.34/device2025-02: 0 reports for this device; peer average 4.03/device2025-03: 0 reports for this device; peer average 5.83/device2025-04: 0 reports for this device; peer average 3.25/device2025-05: 0 reports for this device; peer average 3.93/device2025-06: 0 reports for this device; peer average 4.11/device2025-07: 0 reports for this device; peer average 4.1/device2025-08: 0 reports for this device; peer average 5.45/device2025-09: 0 reports for this device; peer average 6.52/device2025-10: 0 reports for this device; peer average 9.71/device2025-11: 0 reports for this device; peer average 12.53/device2025-12: 0 reports for this device; peer average 18.81/device2026-01: 0 reports for this device; peer average 11.99/device2026-02: 0 reports for this device; peer average 6.63/device2026-03: 0 reports for this device; peer average 8.63/device2026-04: 0 reports for this device; peer average 11.88/device2026-05: 0 reports for this device; peer average 16.78/device2026-06: 0 reports for this device; peer average 15.26/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.15
2019-0205.46
2019-0305.81
2019-0403.3
2019-0505.27
2019-0606.28
2019-0705.59
2019-0807.45
2019-0903.92
2019-1003.57
2019-1104.04
2019-1204.84
2020-0102.75
2020-0205.41
2020-0305.5
2020-0405.17
2020-0502.89
2020-0603.16
2020-0704.32
2020-0802.93
2020-0902.07
2020-1003.79
2020-1104.01
2020-1205.87
2021-0106.53
2021-0204.61
2021-0307.44
2021-0404.17
2021-0505.98
2021-0606.44
2021-0708.34
2021-0807.22
2021-0909.35
2021-1005.7
2021-1106.88
2021-1209.64
2022-0106.49
2022-0208.37
2022-0307.24
2022-0408.11
2022-0509.67
2022-0607.56
2022-0707.46
2022-0805.42
2022-0904.73
2022-1004.62
2022-1104.41
2022-1205.16
2023-0105.01
2023-0204.61
2023-0305.75
2023-0403.78
2023-0506.15
2023-0604.06
2023-0704.25
2023-0805.94
2023-0905.7
2023-1006.69
2023-1105.36
2023-1205.47
2024-0106.28
2024-0204.31
2024-0305.97
2024-0405.86
2024-0504.16
2024-0605.85
2024-0704.97
2024-0805.4
2024-0905.79
2024-1006.4
2024-1104.03
2024-12011.27
2025-0104.34
2025-0204.03
2025-0305.83
2025-0403.25
2025-0503.93
2025-0604.11
2025-0704.1
2025-0805.45
2025-0906.52
2025-1009.71
2025-11012.53
2025-12018.81
2026-01011.99
2026-0206.63
2026-0308.63
2026-04011.88
2026-05016.78
2026-06015.26
This device (reports/month)Average device in ITX, IYN, IYO (reports/device/month)

Regulatory clearances

  • K203406 SESE 2021-02-23 (k number procode)

Predicate lineage

K203406 — cites (transitively): K192226 (d1), K162549 (d2), K152899 (d3), K153480 (d3), K120321 (d4), K133833 (d4), K130304 (d4), K132304 (d4), K141261 (d4), K043535 (d5), K051993 (d5), K904834 (d5), K991580 (d5), K130499 (d5), K070907 (d5), K101874 (d5), K131527 (d5), K073297 (d6), K092271 (d6), K123564 (d6), K111582 (d7), K122327 (d7), K122921 (d7) — cited as predicate by K220068, K223771, K232500, K242519, K251268

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Philips Ultrasound LLC

  • Warning Letter 2025-09-09 Philips Ultrasound, Inc
  • OAI 2025-03-13 Philips Ultrasound, Inc · 4 citations
  • OAI 2025-01-31 Philips Ultrasound, LLC · 6 citations
  • VAI 2024-08-08 Philips Ultrasound, Inc. · 0 citations
  • NAI 2021-11-10 Philips Ultrasound, LLC · 0 citations
  • NAI 2012-09-05 Philips Ultrasound, Inc · 0 citations
  • VAI 2011-12-09 Philips Ultrasound, LLC · 4 citations