Lumify Diagnostic Ultrasound System
K223771Philips Ultrasound · cleared 2023-05-04 · product code IYN · Radiology
Premarket evidence — what FDA accepted
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. It is intended to be used by trained professionals at various settings of patient point of care such as clinical admission, periodic evaluations, and prior to hospitalization discharge. The Lumify system is compatible with iOS or Android operating systems. The B-lines feature is compatible only with Android operating systems and utilizes: A commercial off-the-shelf (COTS) Android mobile device (smart phone or tablet) The Philips Ultrasound Lumify software running as an application on the COTS device The Philips C5-2 Curved array USB transducer The Philips L12-4 Linear array USB transducer The Philips S4-1 Sector array USB transducer Lumify Micro B Transducer Cable Lumify Micro C Transducer Cable”
source quote (p.7)
“The Expanded B-lines Software Feature, with the updated merged B-line detection feature, uses machine learning as part of the algorithm design. Relevant image features extracted from a lung ultrasound cine loop are provided to a machine learning classifier that identifies B-lines and/or merged B-lines in each frame.”
source quote (p.7)
“The algorithm, that used artificial intelligence/machine learning in its development, is locked (meaning no further adjustments by the algorithm are made and it does not continue to learn once commercialized).”
Validation studies (1)
Retrospective clinical
n=157 patients
endpoints: merged B-lines detection; B-line counting; AI agreement to clinicians
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
Reported performance (3 observations)
source quote (p.10)
“For merged B-line detection, the sensitivity, specificity, and accuracy (where confidence interval is abbreviated as CI) were as follows: ... All 416 0.83 (0.77, 0.88)”
source quote (p.10)
“For merged B-line detection, the sensitivity, specificity, and accuracy (where confidence interval is abbreviated as CI) were as follows: ... All 416 ... 0.92 (0.88, 0.96)”
source quote (p.10)
“For B-line counting, the intraclass correlation coefficient (ICC) for maximum B-line count was as follows: ... All 416 ... 0.91 (0.89, 0.93)”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K232500 (decision 2023-10-26) from Philips Ultrasound 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:K232500
- 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).