EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

K233788

Philips Ultrasound LLC · cleared 2024-02-13 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.10)
“The Smart Doppler View ID algorithm is an Artificial Intelligence (AI) based tool that automates the navigation of the touch screen groups on the Ultrasound System associated with Doppler Measurements.”
AlgorithmArtificial Intelligence (AI) based tool
source quote (p.10)
“The Smart Doppler View ID algorithm is an Artificial Intelligence (AI) based tool that automates the navigation of the touch screen groups on the Ultrasound System associated with Doppler Measurements.”
Adaptive (vs locked)No
source quote (p.10)
“The data used for the clinical performance study were completely distinct from that used during training of the algorithm, and there was no overlap between the two data sets.”
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

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

Retrospective clinical

n=400 patients · 1 site(s)

endpoints: accuracy

Reported performance (1 observation)

accuracy0.975CI 95%CI 96.3%, 98.3%
source quote (p.11)
“The results of the primary endpoint analysis demonstrated algorithm accuracy of 97.5% (95%CI 96.3%, 98.3%), p-value <0.0001, thereby meeting the acceptance criteria for the study.”

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
15
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 9 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/K233788