Lumify Diagnostic Ultrasound System

K232500

Philips Ultrasound · cleared 2023-10-26 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The Philips Lumify Diagnostic Ultrasound System (Lumify) is a mobile, durable, and reusable, software-controlled medical device, which is intended to acquire high-resolution ultrasound data and to display the data in B (2D), Pulsed Wave Doppler, Color Doppler, Combined (B+ Color), and M modes. 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.”
AlgorithmArtificial Intelligence (AI) based tool for automated assessment of global LV function, using image segmentation for border detection and tracking processed by neural network.
source quote (p.6)
“Auto EF is a new Artificial Intelligence (AI) feature available on the S4-1 transducer in the Cardiac Preset on the Lumify application based on the LVivo EF algorithm developed by DiA. The LVivo EF algorithm is an Artificial Intelligence (AI) based tool that enables automated assessment of the global LV function. Image segmentation for border detection and tracking includes processing by neural network”
Adaptive (vs locked)No
source quote (p.6)
“Auto EF only includes a mechanism for automatically rejecting false results. If the algorithm fails to compute the results, then the user is notified by displaying an error dialog. Additionally, the tool offers editing functionality to review and adjust the LV contour before accepting it for calculating the results.”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=80 patients

endpoints: correlation of EF measurements; correlation of EDV; correlation of ESV

standards: IEC 62304 Medical device software - Software life cycle processes, 2006 + A 2015, IEC62366 - Medical devices – Part 1: Application of usability engineering to medical devices, 2015, ISO 14971 Medical devices- Application of risk management to medical devices, 2019

Reported performance (1 observation)

f1as written: “correlation (r) for EF measurements”0.82CI 95% CI (0.72, 0.88)
source quote (p.13)
“Strong correlation was demonstrated between LVivo EF ejection fraction (EF) measurements and the average results by manual tracing, r=0.82, 95% CI (0.72, 0.88), meeting the end point criteria.”

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

85
recalls in product code, 24mo
554
MAUDE reports in code, 12mo
+85%
vs code's own 3-yr baseline
5
drift signals on this device
  • 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

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Philips Ultrasound, LLC) — same firm and product code, not necessarily this device · initiated 2025-10-31

    Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.

    recall event 97843 (openFDA)

  • Recalling firm matches this device's applicant (Philips Ultrasound, Inc) — same firm and product code, not necessarily this device · initiated 2025-07-03

    To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

    recall event 97217 (openFDA)

  • Recalling firm matches this device's applicant (Philips Ultrasound, Inc) — same firm and product code, not necessarily this device · initiated 2025-07-03

    To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

    recall event 97217 (openFDA)

  • Recalling firm matches this device's applicant (Philips Ultrasound, Inc) — same firm and product code, not necessarily this device · initiated 2025-07-03

    To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

    recall event 97217 (openFDA)

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K232500