Radiology AI Directory

FDA-cleared profile

Venue

GE Medical Systems Ultrasound and Primary Care Diagnostics

Authorized purpose: Venue is a mobile point-of-care diagnostic ultrasound system for broad adult and pediatric applications in emergency, critical-care, office, clinic, and hospital settings; K180599 adds transesophageal support, ECG synchronization, and an automated eFAST navigation and review workflow.

Ultrasound 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: Venue is a mobile point-of-care diagnostic ultrasound system for broad adult and pediatric applications in emergency, critical-care, office, clinic, and hospital settings; K180599 adds transesophageal support, ECG synchronization, and an automated eFAST navigation and review workflow.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Venue is a mobile point-of-care diagnostic ultrasound system for broad adult and pediatric applications in emergency, critical-care, office, clinic, and hospital settings; K180599 adds transesophageal support, ECG synchronization, and an automated eFAST navigation and review workflow.

Evidence takeaway

Evidence from the reviewed source record: K180599 reports system, software, acoustic-output, biocompatibility, cleaning, electrical, electromagnetic, mechanical, DICOM, and workflow verification. Clinical studies were not required and no numerical AI performance result is disclosed.

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
Venue is a mobile point-of-care diagnostic ultrasound system for broad adult and pediatric applications in emergency, critical-care, office, clinic, and hospital settings; K180599 adds transesophageal support, ECG synchronization, and an automated eFAST navigation and review workflow.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Clinical-use display mirrors the exact FDA-supported purpose reconciled from the decision-summary packet.

Intended users
qualified healthcare professionals
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact indications use the general user class qualified healthcare professionals and do not narrow it to physicians or point-of-care ultrasound professionals.

Care setting and population
Emergency and critical-care departments plus point-of-care areas in offices, clinics, and hospitals.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Workflow role
Broad point-of-care ultrasound acquisition, measurement, reporting, and protocol navigation.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Required input
Live ultrasound data from supported probes plus optional ECG input for image synchronization.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Output and human action
Ultrasound images, measurements, reports, DICOM studies, and eFAST navigation or review information.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Limitations
ECG is not intended for monitoring or diagnosis.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

The exact device description states this ECG boundary; later Venue nerve, B-line, EF, and other AI functions are not established by this packet.

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
K180599
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Anatomy
Multi-region
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-19

Exact FDA decision-summary packet reviewed on 2026-09-19; existing wording is supported without expansion.

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2018-05-02
  • 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
DICOM storage, archive, printing, wireless communication, barcode workflow, and optional ECG; validate worklist, patient matching, probes, archive completeness, ECG timing, and downtime.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Deployment and data flow
Mobile battery-powered ultrasound system with supported probes, cleanable touch interface, articulated display, and network options.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-03

Public materials reviewed for this batch do not establish the complete security posture for the exact release. Request data-flow, identity, audit, encryption, retention, support-access, vulnerability-management, backup, and incident-response evidence.

Training and support
Only qualified physicians and trained point-of-care ultrasound professionals. should operate or interpret the system. Local onboarding should cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-03
Monitoring and change control
Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track the limits that matter for this product: ECG is for image synchronization, not monitoring or diagnosis. K180599 predates later Venue nerve, B-line, EF, and other AI functions; those later capabilities must not be attributed to this release.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K180599 before acceptance.

exact submission · checked 2026-09-03

Later product-family features are not evidence that this cleared release includes them.

Source

Interoperability acceptance

DICOM storage, archive, printing, wireless communication, barcode workflow, and optional ECG; validate worklist, patient matching, probes, archive completeness, ECG timing, and downtime.

exact submission · checked 2026-09-03

Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.

SourceSource

Clinical acceptance

Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. ECG is for image synchronization, not monitoring or diagnosis. K180599 predates later Venue nerve, B-line, EF, and other AI functions; those later capabilities must not be attributed to this release.

exact submission · checked 2026-09-03

Define stop-use, escalation, rollback, and revalidation triggers before production use.

Source

Economic evaluation

Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.

product family · checked 2026-09-03

Vendor productivity claims are scenario inputs, not guaranteed local savings.

Source

Lifecycle monitoring

Monitor by exact hardware, software and model version, patient population, anatomy, protocol, operator, input quality, output edits or overrides, failed studies, repeat acquisition or rework, downstream impact, downtime, incidents, recalls, and updates. Track the limits that matter for this product: ECG is for image synchronization, not monitoring or diagnosis. K180599 predates later Venue nerve, B-line, EF, and other AI functions; those later capabilities must not be attributed to this release.

exact submission · checked 2026-09-03

Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.

SourceSource

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
K180599 reports system, software, acoustic-output, biocompatibility, cleaning, electrical, electromagnetic, mechanical, DICOM, and workflow verification. Clinical studies were not required and no numerical AI performance result is disclosed.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03
Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Sensitivity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or quantitative-biomarker function. Use the task-specific endpoints and tested population reported below.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-03

Specificity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or quantitative-biomarker function. Use the task-specific endpoints and tested population reported below.

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

K180599 FDA performance package for Venue

  • DesignManufacturer nonclinical ultrasound-system, software, probe, DICOM, cleaning, and safety verification
  • PopulationRepresentative emergency, critical-care, and broad point-of-care ultrasound applications
  • Scopeexact submission
  • Tested versionVenue release cleared in K180599
  • IndependenceSponsor or vendor study

K180599

Manufacturer evidence submitted for substantial equivalence; local clinical, technical, and workflow acceptance remains necessary.

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 2026-09-03

No public list price for the exact cleared configuration was found. Obtain a written quote separating hardware or license basis, enabled features, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.

Reimbursement and coding
No separate named-product Medicare payment was identified in the reviewed CMS coverage material. Evaluate the device within the applicable imaging or surgical service line and verify payer, site-of-service, and coding assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-03

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

Build a local total-cost and value model; do not infer reimbursement from FDA clearance.

Source

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
The 2026-09-02 openFDA device-recall snapshot contained no record matched to K180599 by exact submission identifier.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-03

A zero-result exact-identifier search does not prove that no recall, correction, adverse-event report, or product-family safety signal exists.

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.

Exact FDA record reviewedStatus
2026-09-20Last searched
27Fields reviewed
11Source classes checked
20Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads

The refreshed discovery snapshot contains 20 PubMed and 10 ClinicalTrials.gov candidate records. Discovery metadata alone does not establish exact tested-product, version, population, and endpoint applicability, so all candidates remain quarantined and none was promoted. The current discovery snapshot contains 20 PubMed and 10 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 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, reimbursement policy, fda device recall, fda decision summary packet, 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 K180599: Venue

    U.S. Food and Drug Administration - Published 2018-05-02 - Accessed 2026-09-19

    Scope: purpose, modality, anatomy, input, output, intendedUsers, limitations, evidenceSummary, clinicalUse

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. PubMed biomedical literature index

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

    Scope: evidenceDiscovery

  4. ClinicalTrials.gov study registry

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

    Scope: evidenceDiscovery, studyStatus

  5. Medicare Coverage Database

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

    Scope: coverage, codingContext

  6. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  7. Venue point-of-care ultrasound family

    GE HealthCare - Accessed 2026-09-03

    Scope: productFamily, workflowRole, integration, training, implementationCapabilities, currentCommercialContext

Research history

  1. K180599 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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