Radiology AI Directory

FDA-cleared profile

LVivo Software Application

DiA Imaging Analysis Ltd.

Non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function in patients with suspected disease, with Quality Score feedback.

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 relevant medical parameters of structures and function in patients with suspected disease, with Quality Score feedback.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

Identify the intended clinical user and the human action expected after the output.

Care setting and population
Routine transthoracic echocardiography and point-of-care echo workflow; the FDA packet does not specify a facility type.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Offline post-acquisition DICOM-clip analysis with automated frame selection, measurements, quality feedback, manual adjustment or editing, and visual confirmation as part of standard echocardiographic assessment.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM echocardiographic movies or clips from any vendor, including apical 2CH, 3CH, and 4CH views and parasternal short-axis and long-axis views; the platform also processes clips for RV and bladder evaluation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Quality Score feedback plus EF, strain, segmental wall motion, RV, SAX, PLAX, and bladder results; automated LV size and function parameters and measurements with user visualization and editing or confirmation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
The FDA indication is broad, while the reported validation cohort included adults aged 18 years or older in sinus rhythm without multiple premature beats and excluded patients with LBBB. The packet reports 99 of 121 exams automatically analyzed and 90% of 40 additional PLAX exams automatically analyzed; results require clinical review and the study criteria do not establish performance for all patient or rhythm groups.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

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
K240553
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Heart and cardiovascular structures, especially the left and right ventricles; a bladder-volume module is also described
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2024-10-04
  • 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
Processes off-line DICOM clips from any vendor on Windows or Linux, with an Android option for LVivo EF noted in the comparison table. The FDA packet does not establish a specific PACS, RIS, EHR, cloud, or local interface contract.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

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 2026-09-08

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 2026-09-08

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 2026-09-08

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

ACR exact-submission catalog context

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

exact submission ยท checked 2026-09-08
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
FDA clinical validation used 121 routine transthoracic echocardiography patients; 99 exams (82%) were automatically analyzed. The primary endpoint was correlation of Fractional Shortening against the average manual measurements of two sonographers, r=0.79, with an acceptance criterion of at least 0.75. Sensitivity and specificity were each 85% at a 28% cutoff. An additional 40-patient U.S. dataset had 90% automatic analysis; the FDA table reports measurement-specific correlations, bias, and limits of agreement for PLAX parameters, including correlations reported from 0.68 to 0.95. The 28% value is a cutoff, not the sensitivity or specificity.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
85% at the prespecified 28% cutoff.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

The prior 28% values were the cutoff, not sensitivity or specificity; FDA K240553 reports 85% for each endpoint at that cutoff.

Reported specificity
85% at the prespecified 28% cutoff.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

The prior 28% values were the cutoff, not sensitivity or specificity; FDA K240553 reports 85% for each endpoint at that cutoff.

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

LVivo Software Application 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 K240553
  • Samplen=121
  • IndependenceIndependence not established

K240553

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 2026-09-08

No public price or quote for the exact K240553 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

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 K240553. 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 2026-09-08

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
2026-09-08Last searched
20Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting 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 0 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 K240553: LVivo Software Application

    U.S. Food and Drug Administration - Published 2024-10-04 - Accessed 2026-09-08

    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 Software Application model card (K240553)

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

    Scope: output, evidenceSummary, anatomy, evidenceStudies

  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 K240553

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K240553 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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