EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

K251110

Philips Ultrasound LLC · cleared 2025-05-09 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.6)

“The purpose of this Special 510(k) Pre-Market Notification is to modify the Segmental Wall Motion and introduce Auto EF with contrast software application onto the Philips EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound Systems. Auto EF with contrast is an AI based automated software feature that assists clinicians with assessing Left Ventricular Ejection Fraction (LVEF) from images acquired with contrast agent as part of an adult transthoracic echo (TTE) examination.”

AlgorithmThe SWM v2 software is a semi-automated quantitative imaging algorithm. Auto EF with contrast is an AI based automated software feature. SWM v2 is a machine learning-based feature.

source quote (p.6)

“The SWM v2 software is a semi-automated quantitative imaging algorithm, as users are generally expected to review and concur with the initial and generated results. Auto EF with contrast is an AI based automated software feature that assists clinicians with assessing Left Ventricular Ejection Fraction (LVEF) from images acquired with contrast agent as part of an adult transthoracic echo (TTE) examination. A retrospective data analysis study was conducted to assess the use of Segmental Wall Motion (SWM) v2, a machine learning- based feature in quantification of Wall Motion Score Index (WMSI) in transthoracic (TTE) ultrasound clips obtained from subjects referred for clinical TTE exam.”

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: Sensitivity of WMSI; Specificity of WMSI; Correlation coefficient

Retrospective clinical

sample size not stated

endpoints: Pearson's correlation coefficient

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

recalls in product code, 24mo

554

MAUDE reports in code, 12mo

+85%

vs code's own 3-yr baseline

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) K253595 (decision 2026-03-27) from Philips Ultrasound, LLC for a matching device line ("EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K253595
re_clearance
The FDA AI/ML device list shows a newer 510(k) K251651 (decision 2025-10-09) from Philips Ultrasound, LLC for a matching device line ("EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251651
re_clearance
The FDA AI/ML device list shows a newer 510(k) K251455 (decision 2025-07-24) from Philips Ultrasound LLC for a matching device line ("EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251455
re_clearance
The FDA AI/ML device list shows a newer 510(k) K250886 (decision 2025-06-18) from Philips Ultrasound LLC for a matching device line ("EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K250886
re_clearance
The FDA AI/ML device list shows a newer 510(k) K243793 (decision 2025-05-21) from Philips Ultrasound LLC for a matching device line ("EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243793
…and 3 more.

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).