Lumify Diagnostic Ultrasound System
K232500Philips Ultrasound · cleared 2023-10-26 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The Lumify system software provides various imaging features, including an Android-specific feature with artificial intelligence (AI) based, Auto EF Quantification (ejection fraction) technology during cardiac imaging.”
source quote (p.9)
“Image segmentation for border detection and tracking includes processing by neural network”
source quote (p.8)
“The AL/ML functionality is same in the subject device in comparison to the reference device.”
Validation studies (2)
Bench
sample size not stated
standards: IEC 62304 Medical device software - Software life cycle processes, 2006 + A 2015, IEC62366-1 Medical devices – Part 1: Application of usability engineering to medical devices, 2015, ISO 14971 Medical devices- Application of risk management to medical devices, 2019
Retrospective clinical
n=80 patients
endpoints: automated EF evaluation by LVivo EF to Ejection Fraction (EF) evaluation by manual tracing
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (Philips Ultrasound, LLC, initiated 2025-10-31): "Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining." Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:97843
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K252557 (decision 2025-12-22) from Philips Ultrasound, LLC for a matching device line ("Lumify Diagnostic Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K252557
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (GE Medical Systems, LLC, initiated 2025-09-18): "The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97726
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No., initiated 2025-05-16): "GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previou" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:96992
- recall_reason_pattern
Software/algorithm-related recall in product code IYN (Siemens Medical Solutions USA, Inc., initiated 2024-08-15): "If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems wi" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:95254
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).