EPIQ Series Diagnostic Ultrasound System

K233545

Philips Ultrasound LLC · cleared 2023-11-30 · product code IYN · Radiology

Premarket evidence — what FDA accepted

Device typehardware

source quote (p.3)

“The intended use of EPIQ Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body”

AlgorithmFDA source did not state this

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: safety and effectiveness

standards: ANSI/AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, ISO 10993-1

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 10 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).