Radiology AI Directory

FDA-cleared profile

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

Philips Ultrasound LLC

Authorized purpose: EPIQ and Affiniti diagnostic ultrasound systems provide diagnostic ultrasound imaging and fluid-flow analysis across the labeled adult, pediatric, obstetric, cardiac, vascular, abdominal, small-organ, musculoskeletal, urologic, and procedural applications.

Cardiac imagingUltrasound workflow
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Product overview

Start with the essentials

Authorized purpose: EPIQ and Affiniti diagnostic ultrasound systems provide diagnostic ultrasound imaging and fluid-flow analysis across the labeled adult, pediatric, obstetric, cardiac, vascular, abdominal, small-organ, musculoskeletal, urologic, and procedural applications.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: EPIQ and Affiniti diagnostic ultrasound systems provide diagnostic ultrasound imaging and fluid-flow analysis across the labeled adult, pediatric, obstetric, cardiac, vascular, abdominal, small-organ, musculoskeletal, urologic, and procedural applications.

Evidence takeaway

Evidence from the reviewed source record: The exact FDA submission K233788 is the identity anchor. Its public decision material supports the submission-specific product and intended-use summary recorded here; it does not establish a general product-wide sensitivity or specificity value for this dossier.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
EPIQ and Affiniti diagnostic ultrasound systems provide diagnostic ultrasound imaging and fluid-flow analysis across the labeled adult, pediatric, obstetric, cardiac, vascular, abdominal, small-organ, musculoskeletal, urologic, and procedural applications.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Qualified and trained ultrasound professionals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Care setting and population
Hospital, clinic, point-of-care, and procedural settings covered by the exact ultrasound labeling.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Workflow role
Diagnostic ultrasound acquisition, visualization, fluid-flow analysis, and professional review support.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Required input
Ultrasound acquisitions from supported probes, modes, presets, patient populations, and release-specific configurations.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Ultrasound image series, flow data, measurements, and release-specific derived outputs for professional review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Limitations
Probe, mode, anatomy, patient population, acoustic window, workflow, and optional-feature limits vary by exact system and release. EPIQ and Affiniti diagnostic ultrasound systems provide diagnostic ultrasound imaging and fluid-flow analysis across the labeled adult, pediatric, obstetric, cardiac, vascular, abdominal, small-organ, musculoskeletal, urologic, and procedural applications.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K233788
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-02-13
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
Standards-based DICOM/PACS integration was identified in the FDA submission materials; compatibility with a specific PACS, RIS, EHR, or orchestrator requires confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.

Deployment and data flow
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Exact deployment topology, hosting, network boundaries, update mechanism, and local operational requirements are not established for this submission.

Security and privacy
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

Public sources reviewed here do not establish the complete exact-release security posture, including identity, audit, encryption, retention, remote access, vulnerability management, backup, or incident response.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

Workflow role

Diagnostic ultrasound acquisition, visualization, fluid-flow analysis, and professional review support.

exact submission · checked 2026-09-04

This is a submission-anchored intended-use summary, not a local acceptance result.

Source

Input

Ultrasound acquisitions from supported probes, modes, presets, patient populations, and release-specific configurations.

exact submission · checked 2026-09-04

Exact supported inputs and protocol limits must be confirmed from the complete labeling.

Source

Output

Ultrasound image series, flow data, measurements, and release-specific derived outputs for professional review.

exact submission · checked 2026-09-04

Output review, editing, and downstream use remain release- and site-specific.

Source

Vendor family context

Current vendor material is product-family context for K233788 only; exact release, enabled options, deployment, and local interoperability require confirmation.

product family · checked 2026-09-04

Vendor material is not exact-release evidence unless that linkage is separately proven.

Source

Site validation status

Exact local interfaces, deployment topology, security controls, downtime behavior, and support obligations remain unestablished.

exact submission · checked 2026-09-04

Obtain organization-specific implementation evidence before procurement or clinical use.

Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
The exact FDA submission K233788 is the identity anchor. Its public decision material supports the submission-specific product and intended-use summary recorded here; it does not establish a general product-wide sensitivity or specificity value for this dossier.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Reported sensitivity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact submission and version-linked sensitivity endpoint is published in this dossier; do not substitute a product-family or candidate-study value.

Reported specificity
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No exact submission and version-linked specificity endpoint is published in this dossier; do not substitute a product-family or candidate-study value.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

FDA submission-specific verification and validation evidence for K233788

  • DesignRegulatory verification, validation, and labeling evidence reviewed for exact FDA submission K233788.
  • PopulationThe labeled population and test materials for exact submission K233788; a general clinical study population is not established here.
  • Scopeexact submission
  • Tested versionEPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (K233788)
  • IndependenceSponsor or vendor study

K233788

FDA regulatory evidence is submission-specific but is not independent clinical performance evidence.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

No public exact-release price, license fee, subscription, contract, or implementation cost was established in this review.

Reimbursement and coding
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

CMS index context was checked, but no product-specific coverage or reimbursement determination is inferred.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
FDA recall Z-2409-2025 is associated with native exact submission identifier K233788. Status: Open, Classified. Product: X5-1c Transducer Probe. Reason: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Each published event was manually matched to the exact FDA submission and affected product or version; a recall does not establish an AI-algorithm defect or current site exposure unless the event states that scope.

recall: Z-2409-2025

Open, Classified

2025-08-22

Native exact-submission identifier match from the openFDA candidate snapshot accessed 2026-09-04 with source snapshot date 2026-09-02. Source URL: https://api.fda.gov/device/recall.json?search=product_res_number.exact%3A%22Z-2409-2025%22&limit=1. This does not establish exact installed serial, lot, unit, or software-version applicability.

Source

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-04Last searched
29Fields reviewed
13Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. 1 FDA recall candidate was manually reviewed: 1 published and 0 rejected as a neighboring or otherwise inapplicable version. Native FDA recall identifiers produced 1 postmarket candidate record; 1 has been reviewed (1 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

Source classes: fda ai list, fda decision summary, vendor product page, implementation documentation, reimbursement policy, peer reviewed literature, clinical trial registry, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA decision summary for K233788 - EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

    U.S. Food and Drug Administration - Published 2024-02-13 - Accessed 2026-09-04

    Scope: regulatoryIdentity, productIdentity, indication, modality, anatomy, workflowRole, input, output, limitations, evidenceSummary

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. FDA recall Z-2409-2025: X5-1c Transducer Probe

    U.S. Food and Drug Administration - Published 2025-08-22 - Accessed 2026-09-04

    Scope: postmarketSafety, affectedProduct, recallStatus, correctiveAction

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. Medicare Coverage Database

    Centers for Medicare & Medicaid Services - Accessed 2026-09-01

    Scope: coverage, codingContext

  7. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  8. Philips ultrasound family context

    Philips - Accessed 2026-09-04

    Scope: productFamilyContext, workflowRole, implementationCapabilities

Research history

  1. K233788 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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