EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

K253595

Philips Ultrasound, LLC · cleared 2026-03-27 · product code IYN · Radiology

FDA 510(k) summary for EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (K253595)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
2
Performance observations
0
Product code
IYN
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

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 addition of the Artificial Intelligence (AI) Auto Measure Abdomen feature software application onto the EPIQ Series Diagnostic Ultrasound Systems and Affiniti Series Diagnostic Ultrasound Systems.”
AlgorithmArtificial Intelligence (AI) Auto Measure Abdomen feature software application
source quote (p.7)
“The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the addition of the Artificial Intelligence (AI) Auto Measure Abdomen feature software application onto the EPIQ Series Diagnostic Ultrasound Systems and Affiniti Series Diagnostic Ultrasound Systems.”
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)

Retrospective clinical

n=150 patients · 3 site(s)

endpoints: concordance between AI measurements and manual measurements (ground truth) for kidney sagittal length, kidney transverse width, kidney transverse height, and spleen length

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

25
recalls in product code, 24mo
594
MAUDE reports in code, 12mo
+95%
vs code's own 3-yr baseline
6
drift signals on this device
  • predicate_cohort_contagion

    K253595 shares predicate K231966 with K241029 (SpineUs™ System), whose product code IYO recorded 8 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K231966 sibling:K241029

  • 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

  • adverse_event_inflection

    MAUDE adverse-event reports for product code IYN: 604 in the 12 months ending 2026-06, vs a 298.7/12mo average over the prior 3 windows (+102%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-15 · openFDA /device/event.json count=date_received product_code=IYN

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (GE Medical Systems, LLC, initiated 2025-09-18): "The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinica" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97726

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (GE Medical Systems China Co., Ltd. Dev. Zone National Hi-Tech; No., initiated 2025-05-16): "GE HealthCare has become aware that the Estimated Fetal Weight (EFW) measurement data feature on the Versana Premier R3 and LOGIQ F R3 series ultrasound systems can display previou" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:96992

  • recall_reason_pattern

    Software/algorithm-related recall in product code IYN (Siemens Medical Solutions USA, Inc., initiated 2024-08-15): "If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems wi" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95254

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 2026-08-26.

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.

Related FDA clearances

More AI/ML devices under product code IYN

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

Alturion Series Diagnostic Ultrasound System

K260667

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cleared 2026-06-29

ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System

K260844

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cleared 2026-06-16

Butterfly Gestational Age Tool

K252148

Butterfly Network, Inc.

cleared 2026-03-27

LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power

K260673

GE Medical Systems Ultrasound and Primary Care Diagnostics

cleared 2026-03-24

Sonio Detect (v3)

K252433

Sonio

cleared 2026-03-16

LOGIQ Totus

K253370

GE Medical Systems Ultrasound and Primary Care Diagnostics

cleared 2026-01-08

LOGIQ Fortis

K253366

GE Medical Systems Ultrasound and Primary Care Diagnostics

cleared 2026-01-07

HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System

K252018

Samsung Medison Co., Ltd.

cleared 2026-01-05

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K253595