Radiology AI Directory

FDA-cleared profile

LVivo IQS

DiA Imaging Analysis Ltd

Non-invasive processing of ultrasound images to detect, measure, and calculate medical parameters of structures and function in patients with suspected disease, with Quality Score feedback; the submitted IQS module provides real-time quality scoring for the left ventricle from the four-chamber apical view.

Cardiac imagingDetection and CADeQuantification and segmentationUltrasound 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.

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
Non-invasive processing of ultrasound images to detect, measure, and calculate medical parameters of structures and function in patients with suspected disease, with Quality Score feedback; the submitted IQS module provides real-time quality scoring for the left ventricle from the four-chamber apical view.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Intended users
Healthcare professionals
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Intended-user text reported in the exact-submission ACR model card.

Care setting and population
Adult routine echocardiography and point-of-care ultrasound workflows; validation included patients older than 18 referred for routine echocardiography and adults with a point-of-care ultrasound indication.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Workflow role
Real-time ultrasound image-quality feedback during acquisition or review, with visual confirmation of results by the user; it is a quality-scoring aid rather than a separately established diagnostic endpoint.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Required input
Ultrasound images and DICOM clips from ultrasound devices; the summary describes left-ventricular four-chamber apical-view clips and offline DICOM clips from any vendor.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Output and human action
Quality Score feedback in real time for the left ventricle from the four-chamber apical view, with quality information that can be reviewed by the user.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Limitations
The FDA indication is broad suspected-disease ultrasound processing, while the submitted performance evidence evaluated image-quality tagging and clinical interpretability in 100 routine echocardiography examinations with 22,663 frames and 64 point-of-care ultrasound patients; the packet does not establish a diagnostic-outcome claim.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09

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
K222970
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Anatomy
Heart; left ventricle from the four-chamber apical view
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-02-01
  • 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 packet describes an API/software component to be integrated by another programmer into a legally marketed ultrasound imaging device and supports DICOM clips; it does not establish universal PACS, RIS, EHR, or other interfaces.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Supported acquisition environment

Scanner manufacturers: All

exact submission · checked 2026-09-01

Confirm currently supported software versions, protocols, and site-specific acquisition configurations.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for LVivo IQS; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-09
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
Validation against experienced-sonographer quality tags used 100 patient examinations and 22,663 frames; the success criterion was 75% overall agreement and observed agreement was 81%. A separate 64-patient point-of-care study required 80% of visually acceptable clips to receive at least a Medium score and 90% clinical interpretability; 90% met the Medium-or-better criterion and 93% of those clips were clinically interpretable. These are agreement, threshold, and interpretability endpoints, not sensitivity or specificity.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-09
Reported sensitivity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

Reported specificity
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

This field has not been curated yet.

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

LVivo IQS regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationPopulation described in the exact-submission ACR model card
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K222970
  • Samplen=100
  • IndependenceIndependence not established

K222970

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

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
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-09

No public price or quote for the exact K222970 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-09

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

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 exact-identifier FDA recall query returned no native recall record for K222970. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-09

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
2026-09-09Last searched
21Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
1Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 1 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, acr ai central product, 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 K222970: LVivo IQS

    U.S. Food and Drug Administration - Published 2023-02-01 - Accessed 2026-09-09

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

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

    Scope: regulatoryIdentity, modalityContext

  3. LVivo IQS model card (K222970)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

    Scope: intendedUsers, output, limitations, evidenceSummary, anatomy, evidenceStudies, implementationCapabilities

  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. openFDA Device Recall API

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

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K222970

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

    Scope: postmarketSafety

Research history

  1. K222970 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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