Radiology AI Directory

FDA-cleared profile

Vivid iq

GE Medical Systems Ultrasound and Primary Care Diagnostics

Authorized purpose: Vivid iq is a compact Track 3 general-purpose diagnostic ultrasound system for trained healthcare professionals, with labeled cardiac, vascular, abdominal, obstetric, small-organ, musculoskeletal, urologic, transcranial, transrectal, transvaginal, transesophageal, interventional, thoracic, and intraoperative 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: Vivid iq is a compact Track 3 general-purpose diagnostic ultrasound system for trained healthcare professionals, with labeled cardiac, vascular, abdominal, obstetric, small-organ, musculoskeletal, urologic, transcranial, transrectal, transvaginal, transesophageal, interventional, thoracic, and intraoperative applications.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Vivid iq is a compact Track 3 general-purpose diagnostic ultrasound system for trained healthcare professionals, with labeled cardiac, vascular, abdominal, obstetric, small-organ, musculoskeletal, urologic, transcranial, transrectal, transvaginal, transesophageal, interventional, thoracic, and intraoperative applications.

Evidence takeaway

Evidence from the reviewed source record: The exact FDA material supports the broad labeled Vivid iq ultrasound scope; preserved exact-product evidence records a Sleep Mode daily power-reduction metric and selected software or interoperability functions without generalizing them to other configurations.

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
Vivid iq is a compact Track 3 general-purpose diagnostic ultrasound system for trained healthcare professionals, with labeled cardiac, vascular, abdominal, obstetric, small-organ, musculoskeletal, urologic, transcranial, transrectal, transvaginal, transesophageal, interventional, thoracic, and intraoperative applications.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Intended users
Trained physicians, sonographers, and other qualified healthcare professionals operating the supported ultrasound system and probes.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Prior source-backed dossier value: Qualified physicians, sonographers, and other trained diagnostic or interventional ultrasound professionals.

Care setting and population
Hospitals, echocardiography laboratories, operating rooms, catheterization or electrophysiology laboratories, private offices, and other labeled ultrasound settings.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Prior source-backed dossier value: Hospitals, operating rooms, catheterization or electrophysiology labs, private offices, and limited labeled settings outside healthcare facilities.

Workflow role
Acquires and displays ultrasound data and supports labeled cardiac, vascular, shared-service, interventional, and other clinical applications with measurement and review.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Prior source-backed dossier value: Portable cardiovascular and general ultrasound acquisition, measurement, analysis, procedural support, and report exchange.

Required input
Real-time ultrasound signals from compatible transthoracic, transesophageal, vascular, and procedural probes plus optional ECG.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Output and human action
Diagnostic ultrasound images, measurements, DICOM-encapsulated PDF, remote-viewing or workflow displays, and supported cardiac, vascular, and shared-service outputs.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Prior source-backed dossier value: Ultrasound images, Doppler information, measurements, analysis, clips, and configured reports.

Limitations
Use depends on the labeled application, probe, patient population, operator training, image quality, and configured system options; remote viewing is not itself diagnostic and clinicians retain interpretation responsibility.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Prior source-backed dossier value: Remote viewing is not for diagnosis. Vascular-access, catheter, probe, AI, and analysis support differ by configuration, and Sleep Mode’s energy result is not a clinical performance endpoint.

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
K243620
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04
Anatomy
Multi-region; cardiovascular and shared-service ultrasound applications
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Prior source-backed dossier value: Heart/Cardiovascular

Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-02-11
  • 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
The FDA and preserved exact-product evidence describe supported probes and catheters, DICOM-encapsulated PDF, remote viewing, Carto 3, Vascular Access, and the system's clinical applications.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is the interface boundary described in the exact FDA decision material; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing. Prior source-backed dossier value: DICOM networking with encapsulated PDF support in the cleared release; validate measurement, structured-report, clip, worklist, and PACS behavior.

Deployment and data flow
The FDA material describes a compact mobile-cart ultrasound console; current room, network, archive, service, security, and enabled-option configuration remain unverified.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

This is the release-level boundary described in the exact FDA decision material; current hosting, contracts, security, availability, upgrade path, and site configuration remain separate evidence. Prior source-backed dossier value: Portable cardiovascular ultrasound console with model-specific probes, battery, software, networking, and service options.

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

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

Training and support
Only Trained physicians, sonographers, and other qualified healthcare professionals operating the supported ultrasound system and probes should operate or interpret the product; local onboarding must cover the exact release, supported population, limitations, failure examples, escalation, downtime, and competency documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Prior source-backed dossier value: Only qualified physicians, sonographers, and other trained diagnostic or interventional 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.

Monitoring and change control
Monitor K243620 by exact hardware, software, model, algorithm 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 these product-specific limits: Use depends on the labeled application, probe, patient population, operator training, image quality, and configured system options; remote viewing is not itself diagnostic and clinicians retain interpretation responsibility.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Buyer-facing monitoring guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service. Prior source-backed dossier value: 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: Remote viewing is not for diagnosis. Vascular-access, catheter, probe, AI, and analysis support differ by configuration, and Sleep Mode’s energy result is not a clinical performance endpoint.

Release and scope verification

Map the installed model, build, options, population, anatomy, inputs, and outputs to K243620 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 networking with encapsulated PDF support in the cleared release; validate measurement, structured-report, clip, worklist, and PACS behavior.

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. Remote viewing is not for diagnosis. Vascular-access, catheter, probe, AI, and analysis support differ by configuration, and Sleep Mode’s energy result is not a clinical performance endpoint.

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: Remote viewing is not for diagnosis. Vascular-access, catheter, probe, AI, and analysis support differ by configuration, and Sleep Mode’s energy result is not a clinical performance endpoint.

exact submission · checked 2026-09-03

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

SourceSource

Deployment boundary

The FDA material describes a compact mobile-cart ultrasound console; current room, network, archive, service, security, and enabled-option configuration remain unverified.

exact submission · checked 2026-09-04

FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.

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 material supports the broad labeled Vivid iq ultrasound scope; preserved exact-product evidence records a Sleep Mode daily power-reduction metric and selected software or interoperability functions without generalizing them to other configurations.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-04

Prior source-backed dossier value: K243620 describes manufacturer system, probe, image-quality, software, DICOM, Sleep Mode, and application testing. Current vendor workflow claims are product-family supplied and require local verification.

Reported sensitivity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Sensitivity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below. Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.

Reported specificity
Not applicable
  • Not applicable
  • Not applicable
  • Checked 2026-09-04

Specificity is not the primary applicable endpoint for this acquisition, reconstruction, segmentation, planning, guidance, or dose-delivery function. Use the task-specific endpoints and tested population reported below. Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.

Sleep Mode daily power reduction

22 %

  • EndpointDaily power consumption reduction described for the cleared Sleep Mode
  • PopulationVivid iq
  • Tested versionVivid iq release cleared in K243620
Source

K243620 FDA performance package for Vivid iq

  • DesignManufacturer ultrasound-system, probe, acoustic-output, image-quality, software, energy-use, interoperability, and usability verification
  • PopulationRepresentative cardiovascular, vascular-access, thoracic, intraoperative, and interventional ultrasound workflows
  • Scopeexact submission
  • Tested versionVivid iq release cleared in K243620
  • IndependenceSponsor or vendor study

K243620

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 2026-09-04

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. Obtain a written quote separating hardware or license basis, 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 product within the applicable imaging or clinical service line and verify payer, site-of-service, coding, and coverage assumptions independently.
  • Public source
  • Not applicable
  • Checked 2026-09-04

Prior source-backed dossier value: 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.

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

No product-specific code

No separate named-product payment identified in reviewed public material

Centers for Medicare & Medicaid Services · United States

This is not a product-specific reimbursement determination. Verify payer, site-of-service, coding, and coverage assumptions independently.

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 K243620 by exact native submission identifier. This does not exclude product-family, later-version, or adverse-event information.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-04

Exact-identifier review does not prove absence of all product-family safety signals. Prior source-backed dossier value: The 2026-09-02 openFDA device-recall snapshot contained no record matched to K243620 by exact submission identifier.

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
32Fields reviewed
11Source classes checked
2Screened PubMed leads
10Screened trial leads
0Unreviewed FDA recall leads

Screened two PubMed and 10 ClinicalTrials.gov records. Some records use or mention Vivid iq hardware, but none identifies the tested release and enabled options as the exact K243620 configuration; all 12 were quarantined and none was promoted. The current discovery snapshot contains 2 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, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, vendor product page, 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 510(k) decision material K243620: Vivid iq

    U.S. Food and Drug Administration - Published 2025-02-11 - Accessed 2026-09-04

    Scope: identity, productIdentity, purpose, clinicalUse, modality, anatomy, intendedUsers, careSetting, 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. 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. Vivid iq cardiovascular ultrasound system

    GE HealthCare - Accessed 2026-09-03

    Scope: productFamily, workflowRole, implementationCapabilities, currentCommercialContext

Research history

  1. K243620 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

Alternatives

Related tools to compare

FDA-cleared K260667

Alturion Series Diagnostic Ultrasound System

Philips Ultrasound, LLC

Alturion Series diagnostic ultrasound systems acquire and display ultrasound images and fluid-flow information for the labeled fetal, abdominal, cardiac, cephalic, obstetric,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal anatomy; ophthalmic; urologic organs; and lung
Decision
2026-06-29
Cardiac imagingUltrasound workflow
FDA-cleared K260844

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

Siemens Medical Solutions USA, Inc.

ACUSON Sequoia, Select, Origin, and Origin ICE diagnostic ultrasound systems acquire and display the labeled fetal, abdominal, pediatric, neonatal, cephalic, small-part,...

Modality
Ultrasound
Anatomy
Fetus; abdomen; pelvis; small organs; head; heart; peripheral vessels; musculoskeletal anatomy; transesophageal and intracardiac applications
Decision
2026-06-16
Cardiac imagingUltrasound workflow
FDA-cleared K260300

WatchMate Software

Anumana, Inc.

WatchMate Software v1.2.0 processes transesophageal echocardiography data to reconstruct the left atrial appendage and assist preprocedural planning and device sizing during...

Modality
Ultrasound
Anatomy
Heart and left atrial appendage
Decision
2026-06-15
Cardiac imagingUltrasound workflow
FDA-cleared K260780

HeartFocus

Deski

Guides medical professionals acquiring ten standard 2D transthoracic echocardiographic views in adults requiring a cardiac ultrasound examination; acquired images require...

Modality
Ultrasound
Anatomy
Heart/Cardiovascular
Decision
2026-06-03
Cardiac imagingUltrasound workflow