Result destination
PACS is explicitly referenced as a result destination.
exact submission · checked 2026-09-01Confirm supported products, versions, routing behavior, and display requirements during local evaluation.
FDA-cleared profile
Fetal EchoScan (v1.2)
Brightheart
Fetal EchoScan is a machine learning-based computer-assisted diagnosis (CADx) software device indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams. When utilized by an interpreting physician, Fetal EchoScan provides information regarding the presence of any of the following suspicious radiographic findings: overriding artery, septal defect at the cardiac crux, abnormal relationship of the outflow tracts, enlarged cardiothoracic ratio, right ventricular to left ventricular size discrepancy, tricuspid valve to mitral valve annular size discrepancy, pulmonary valve to aortic valve annular size discrepancy, cardiac axis deviation Fetal EchoScan is to be used with cardiac fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, right ventricular outflow tract standard views. Fetal EchoScan is intended for use as a concurrent reading aid for interpreting physicians. It does not replace the role of the physician or of other diagnostic testing in the standard of care. When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis regarding the potential presence of morphological abnormalities that might be suggestive of fetal congenital heart defects that may be useful in determining the need for additional exams. Fetal EchoScan is not intended for use in multiple pregnancies, cases of fetal heterotaxy and postnatal ultrasound exams.
Evidence status: each field shows source quality, applicability, and review date. Research pending, information not established in reviewed sources, and vendor documentation pending are distinct outcomes.
Clinical fit
What this tool is for
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
- Exact purpose
- Fetal EchoScan is a machine learning-based computer-assisted diagnosis (CADx) software device indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams. When utilized by an interpreting physician, Fetal EchoScan provides information regarding the presence of any of the following suspicious radiographic findings: overriding artery, septal defect at the cardiac crux, abnormal relationship of the outflow tracts, enlarged cardiothoracic ratio, right ventricular to left ventricular size discrepancy, tricuspid valve to mitral valve annular size discrepancy, pulmonary valve to aortic valve annular size discrepancy, cardiac axis deviation Fetal EchoScan is to be used with cardiac fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, right ventricular outflow tract standard views. Fetal EchoScan is intended for use as a concurrent reading aid for interpreting physicians. It does not replace the role of the physician or of other diagnostic testing in the standard of care. When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis regarding the potential presence of morphological abnormalities that might be suggestive of fetal congenital heart defects that may be useful in determining the need for additional exams. Fetal EchoScan is not intended for use in multiple pregnancies, cases of fetal heterotaxy and postnatal ultrasound exams.
Exact-submission indication text from the ACR AI Central model card. FDA labeling remains controlling.
- Intended users
- Interpreting physicians (OB-GYNs and Maternal-Fetal Medicine specialists)
Intended-user text reported in the exact-submission ACR model card.
- Care setting and population
- Adult
Patient-population text reported in the exact-submission ACR model card; institutional setting may still require vendor confirmation.
- Workflow role
- Detection, localization, or diagnostic support
Conservative normalization of explicit wording in an exact-submission source.
- Required input
- US images or data. Inclusion criteria: Cardiac fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, and right ventricular outflow tract standard views; pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams (18 to 24 weeks of gestational age)
Conservative normalization of explicit wording in an exact-submission source.
- Output and human action
- For each frame, the software evaluates whether the following findings are present, absent, or inconclusive: overriding artery, septal defect at the cardiac crux, abnormal relationship of the outflow tracts, enlarged cardiothoracic ratio, right ventricular to left ventricular size discrepancy, tricuspid valve to mitral valve annular size discrepancy, pulmonary valve to aortic valve annular size discrepancy, and cardiac axis deviation. An exam summary table displays a summary of the results for the overall study. Outputs are displayed as annotated DICOMs within the user PACS viewer and optionally on a third-party user interface.
Clinical output reported in the exact-submission ACR model card.
- Limitations
- Exclusion criteria: Multiple pregnancies, cases of fetal heterotaxy and postnatal ultrasound exams
Limitations and supported-acquisition details reported in the exact-submission ACR model card.
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
- K252294
- Modality
- Ultrasound
Imaging modality reported in the exact-submission ACR AI Central model card.
- Anatomy
- Obstetric/Fetal
Anatomy normalized from explicit exact-submission ACR model-card wording.
- Clearance type
- 510(k)
- Decision date
- 2025-12-08
- FDA status
- FDA-cleared
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- The exact-submission ACR model card explicitly references PACS in the described input, output, or workflow; exact interfaces, versions, and local compatibility require confirmation.
Interoperability terms explicitly reported in the exact-submission ACR model card; interface versions and local compatibility still require confirmation.
- Deployment and data flow
- Hybrid
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
- Security and privacy
- Vendor documentation pending
FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
- Training and support
- Vendor documentation pending
Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Monitoring and change control
- Vendor documentation pending
Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
Evidence
Performance evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
- Evidence summary
- Study type: Both. Cases: 877. Sites: 11. Reported sensitivity: 98.4% (95% CI: 96.3%, 99.3%). Reported specificity: 97% (95% CI: 95.2%, 98.1%). Reader-study cases: 200. Readers: 14. Reader-study sensitivity: 93.5% (95% CI: 89.2%, 97.8%). Reader-study specificity: 97% (95% CI: 94.9%, 99.1%)
Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.
- Reported sensitivity
- 98.4% (95% CI: 96.3%, 99.3%)
Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
- Reported specificity
- 97% (95% CI: 95.2%, 98.1%)
Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
Fetal EchoScan (v1.2) regulatory performance study summary
Stand-alone performance and reader study (ACR AI Central category) · Adult
exact submission · Tested version: 1.2 · n=877 · 11 sites · Independence not establishedK252294
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
Economics and lifecycle
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
FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
- Reimbursement and coding
- Research pending
Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
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
- Not established in reviewed sources
No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: FDA authorization does not establish the current commercial security posture. Request data-flow diagrams, hosting and retention details, access controls, audit logging, attestations, and incident-response documentation.
- Verify training: Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.
- Verify pricing and total cost: FDA submission materials do not establish current commercial pricing. Request the pricing unit, term, minimum commitment, implementation fees, and included support from the vendor.
- Verify reimbursement and coding relevance: Determine whether any product-specific CPT/HCPCS pathway exists and separate it from billing for the underlying imaging service.
- Verify local validation and lifecycle monitoring: Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.
- Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-04Last searched
20Fields reviewed
6Source classes checked
0Unreviewed PubMed leads
0Unreviewed 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. 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, pubmed, clinical trials, openfda device recall
Sources
Source ledger
Sources accessed through 2026-09-02.
- K252294 FDA decision source U.S. Food and Drug Administration · 2026-08-31
- Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
- Fetal EchoScan (v1.2) model card (K252294) American College of Radiology · 2026-09-01
- PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
- ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
- openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
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