The 5000 Compact Series Ultrasound Systems

K242800

Philips Ultrasound LLC · cleared 2024-11-15 · product code IYN · Radiology

FDA 510(k) summary for The 5000 Compact Series Ultrasound Systems (K242800)

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 typesamd
source quote (p.6)
“The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Auto Measure Artificial Intelligence-Machine Learning software feature onto the 5000 Compact Series Ultrasound Systems.”
AlgorithmArtificial Intelligence-Machine Learning software feature that utilizes machine learning to provide semi-automated and editable measurements in echocardiography.
source quote (p.6)
“The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Auto Measure Artificial Intelligence-Machine Learning software feature onto the 5000 Compact Series Ultrasound Systems. The Auto Measure feature utilizes machine learning to provide a subset of semi-automated and editable measures during an echocardiography or when reviewing an already acquired echocardiography.”
Adaptive (vs locked)No
source quote (p.6)
“Philips has designed Auto Measure as a "locked" algorithm prior to marketing. As defined by FDA in the discussion paper Proposed Regulatory Framework for Modifications to AI/ML Based Software as a Medical Device (SaMD) published April 2, 2019, this “locked" algorithm provides the same result each time the same input is applied to it and does not change with use.”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=500 patients · 20 site(s)

endpoints: Limits of Agreement (LoA)

standards: IEC 62304, ISO 14971

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

    K242800 shares predicate K211597 with K213544 (TOMTEC-ARENA), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-08-26 · predicate:K211597 sibling:K213544

  • 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

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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

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

K253595

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cleared 2026-03-27

Butterfly Gestational Age Tool

K252148

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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

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K242800