Radiology AI Directory

FDA-cleared profile

Libby Echo:Prio

Dyad Medical, Inc

Process previously acquired DICOM-compliant cardiac ultrasound images and estimate cardiac measurements to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners in clinical decision-making; indicated for adults.

Cardiac imagingQuantification 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
Process previously acquired DICOM-compliant cardiac ultrasound images and estimate cardiac measurements to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners in clinical decision-making; indicated for adults.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Qualified cardiologists, sonographers, or other licensed professional healthcare practitioners
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Medical facility or routine echocardiography workflow using a personal computer or compatible DICOM PACS; adult use is a patient-population boundary, not the care-setting value.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Post-processing echocardiography review and quantification with machine-learning view classification, ED/ES frame identification, LV/LA/LV-myocardium segmentation, sonographer markup and correction, and physician review/reporting.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Previously acquired DICOM-compliant cardiac ultrasound images from adult patients, including the echocardiographic views supported by the software's view-classification and analysis functions.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
2D, cine-loop, and secondary-capture review; echocardiographic view classification; ED and ES frame identification with heartbeat-rate estimates; ejection fraction from LV endocardium, LA, and LV-myocardium segmentation; manually entered or corrected markup; and a generated summary report.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
The workflow uses a skilled sonographer to provide markup and allows automated results to be accepted, partially modified, or rejected before physician review. The device is indicated for adults and supports clinical decision-making as an aid; the packet does not establish autonomous use, a general population beyond adult cardiac ultrasound, or current interface compatibility beyond the described DICOM/PACS or personal-computer configurations.
  • 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
K220956
  • 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, including LV chamber/endocardium, LA, and LV myocardium
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2022-07-20
  • 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 software processes DICOM-compliant cardiac ultrasound images and is described as operating on a personal computer or compatible DICOM PACS; a web-browser interface is also compared. Results are reported through a generated report, and exact interface versions, local compatibility, and current deployment topology are not established.
  • 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.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Libby Echo:Prio; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · 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 performance testing was retrospective on a diverse clinical dataset; the packet does not state a sample size in the reviewed summary. View-classification accuracy was 97% with average F1 greater than 96.6%, average sensitivity 96.8%, and average specificity 98.5%. Heart-rate output had a linear-regression slope of 0.98 against 12-lead ECG, and EF prediction had a bivariate linear-regression slope of 0.79 with 95% CI 0.52-0.98 against annotations by four human experts. These are separate view-classification and measurement-agreement endpoints.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
View-classification sensitivity: 96.8%.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

FDA K220956 reports these as view-classification endpoints; ejection-fraction and heart-rate agreement are separate measurement endpoints.

Reported specificity
View-classification specificity: 98.5%.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

FDA K220956 reports these as view-classification endpoints; ejection-fraction and heart-rate agreement are separate measurement endpoints.

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

Libby Echo:Prio regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K220956
  • IndependenceIndependence not established

K220956

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 K220956 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 K220956. 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
23Fields 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 K220956: Libby Echo:Prio

    U.S. Food and Drug Administration - Published 2022-07-20 - 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. Libby Echo:Prio model card (K220956)

    American College of Radiology - Published 2026-08-17 - Accessed 2026-09-01

    Scope: intendedUsers, careSetting, output, reportedSensitivity, evidenceSummary, integration, 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 K220956

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

    Scope: postmarketSafety

Research history

  1. K220956 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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