The 5000 Compact Series Ultrasound Systems
K242800Philips Ultrasound LLC · cleared 2024-11-15 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Auto Measure Artificial Intelligence-Machine Learning software feature onto the 5000 Compact Series Ultrasound Systems. No hardware changes to the 5000 Compact Series Ultrasound Systems K222648 are required when using the Auto Measure feature, and existing, commercialized Philips transducers are used for the Auto Measure feature.”
source quote (p.6)
“The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Auto Measure Artificial Intelligence-Machine Learning software feature onto the 5000 Compact Series Ultrasound Systems. The Auto Measure feature utilizes machine learning to provide a subset of semi-automated and editable measures during an echocardiography or when reviewing an already acquired echocardiography. Philips has designed Auto Measure as a "locked" algorithm prior to marketing. Since the initial Auto Measure feature initial clearance (Version 1.0), a subset of integrated measurement detectors has been trained with additional training data in the Auto Measure feature (Version 2) which is scope of this submission. Architecture of all detectors, training procedure and all acceptance criteria for the additional training data are identical to Auto Measure Version 1”
source quote (p.6)
“Philips has designed Auto Measure as a "locked" algorithm prior to marketing. As defined by FDA in the discussion paper Proposed Regulatory Framework for Modifications to AI/ML Based Software as a Medical Device (SaMD) published April 2, 2019, this “locked" algorithm provides the same result each time the same input is applied to it and does not change with use.”
Validation studies (1)
Retrospective clinical
n=500 patients · 20 site(s)
endpoints: Limits of Agreement (LoA) compared to clinical ground truth; Meeting acceptance criteria informed by clinical literature
standards: IEC 62304 Medical device software – Software life cycle processes, 2006 + A 2015, ISO 14971 Medical devices- Application of risk management to medical devices, 2019
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
- 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).