EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

K243794

Philips Ultrasound LLC · cleared 2025-02-06 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.7)
“The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the change in AutoMeasure V3 software application onto the EPIQ Series Diagnostic Ultrasound Systems and Affiniti Series Diagnostic Ultrasound Systems. Auto Measure is an optional software feature on the EPIQ Series Diagnostic Ultrasound System that provides the end user with semiautomated adult echocardiography 2D, Doppler or M-mode measurements through an AI-algorithm, training via machine-learning techniques.”
Algorithmsemi-automated adult echocardiography 2D, Doppler or M-mode measurements through an AI-algorithm, training via machine-learning techniques. AutoMeasure V3 is created semi-automatically using machine learning algorithm without user interaction. Semi-automated adult echocardiography 2D and Doppler measurements are generated using an artificial intelligence (AI) detection algorithm without user interaction.
source quote (p.10)
“Auto Measure is an optional software feature on the EPIQ Series Diagnostic Ultrasound System that provides the end user with semiautomated adult echocardiography 2D, Doppler or M-mode measurements through an AI-algorithm, training via machine-learning techniques. AutoMeasure V3 is created semi-automatically using machine learning algorithm without user interaction. Semi-automated adult echocardiography 2D and Doppler measurements are generated using an artificial intelligence (AI) detection algorithm without user interaction.”
Adaptive (vs locked)No
source quote (p.11)
“AutoMeasure V3 is created semi-automatically using machine learning algorithm without user interaction. Semi-automated adult echocardiography 2D and Doppler measurements are generated using an artificial intelligence (AI) detection algorithm without user interaction.”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=3,964 patients

endpoints: agreement of AutoMeasure V3 software with Standard of Care Measurements; confidence intervals for the limits of agreement

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

85
recalls in product code, 24mo
554
MAUDE reports in code, 12mo
+85%
vs code's own 3-yr baseline
11
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 5 more.

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/K243794