Lumify Diagnostic Ultrasound System

K252557

Philips Ultrasound, LLC · cleared 2025-12-22 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.7)
“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 mode (2D), Pulsed Wave Doppler, Color Doppler, Combined (B+ Color), and M modes.”
Algorithmmachine learning algorithms
source quote (p.6)
“It utilizes machine learning algorithms trained on a large dataset of expert-annotated lung ultrasound images to ensure accurate analysis.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

sample size not stated

endpoints: automated classification of lung view quality and pleural line appearance during clinical LUS examinations; algorithm agreement with ground truth labels for binary classification of (1) Adequate versus Poor lung view quality, and (2) Normal versus Irregular pleural line appearance

Reader study (MRMC)

sample size not stated

endpoints: evaluate the performance of the subject device in a simulated clinical setting

Reported performance (4 observations)

agreement_kappaas written: “Lung View Quality algorithm Cohen's kappa”0.67CI 0.61–0.72
source quote (p.12)
“The Lung View Quality algorithm demonstrated substantial agreement with ground truth for binary classification of Adequate vs. Poor views, achieving 87.9% concordance, Cohen’s kappa of 0.67 (95% CI: 0.61–0.72), and PABAK of 0.76 (95% CI: 0.72–0.80).”
agreement_kappaas written: “Lung View Quality algorithm PABAK”0.76CI 0.72–0.80
source quote (p.12)
“The Lung View Quality algorithm demonstrated substantial agreement with ground truth for binary classification of Adequate vs. Poor views, achieving 87.9% concordance, Cohen’s kappa of 0.67 (95% CI: 0.61–0.72), and PABAK of 0.76 (95% CI: 0.72–0.80).”
agreement_kappaas written: “Pleural Line algorithm Cohen's kappa”0.66CI 0.61–0.71
source quote (p.12)
“The Pleural Line algorithm showed substantial agreement with ground truth for binary classification of Normal versus Irregular pleural line, achieving 85.6% concordance, Cohen’s kappa of 0.66 (95% CI: 0.61–0.71), and PABAK of 0.71 (95% CI: 0.67–0.76).”
agreement_kappaas written: “Pleural Line algorithm PABAK”0.71CI 0.67–0.76
source quote (p.12)
“The Pleural Line algorithm showed substantial agreement with ground truth for binary classification of Normal versus Irregular pleural line, achieving 85.6% concordance, Cohen’s kappa of 0.66 (95% CI: 0.61–0.71), and PABAK of 0.71 (95% CI: 0.67–0.76).”

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
4
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

  • 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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K252557