EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
K242020Philips Ultrasound LLC · cleared 2024-12-12 · product code IYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Auto ElastQ software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The Auto ElastQ software feature is intended to assist users in making stiffness measurements using 2D-SWE in the liver by recommending specific frames and ROI positions to the user.”
source quote (p.7)
“The Auto ElastQ software feature is intended to assist the user in making liver stiffness measurements using 2D-SWE through recommended particular frames and ROI positions to the user.”
Validation studies (2)
Bench
sample size not stated
endpoints: acceptance criteria
standards: IEC 62304, ISO 14971
Retrospective clinical
sample size not stated
endpoints: agreement; acceptance criteria
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
- 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 6 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).