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
Authorized purpose: Concurrent CADx aid for suspicious fetal cardiac morphological findings during second-trimester fetal heart ultrasound.
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: Concurrent CADx aid for suspicious fetal cardiac morphological findings during second-trimester fetal heart ultrasound.
Overview status: Source-reviewed overview
- What does this software do? Authorized purpose: Concurrent CADx aid for suspicious fetal cardiac morphological findings during second-trimester fetal heart ultrasound.
- Which images or clinical context are in scope? Modality: Ultrasound Anatomy or clinical context: Fetal Heart / Obstetric Input: Fetal cardiac ultrasound video clips containing interpretable four-chamber, left-ventricular-outflow-tract, and right-ventricular-outflow-tract standard views.
- Who uses it? Intended users: Interpreting physicians.
- What does the software produce? Output: For each frame, present, absent, or inconclusive status for eight suspicious fetal cardiac findings, plus an overall exam summary; annotated DICOMs are displayed in the user PACS viewer and optionally in a validated third-party interface.
- What is its most important limitation? Key limitation: Not for multiple pregnancies, fetal heterotaxy, or postnatal ultrasound. Inconclusive outputs require scenario-specific handling in performance analysis. The packet states validation only with Fujifilm, GE, Philips, Samsung, and Toshiba ultrasound devices.
Clinical takeaway
Clinical role: Concurrent CADx aid for suspicious fetal cardiac morphological findings during second-trimester fetal heart ultrasound.
Evidence takeaway
Evidence from the reviewed source record: FDA standalone testing used 877 second-trimester fetal ultrasound exams from 11 centers, with three pediatric cardiologists providing majority-vote truthing and testing data separate from training. For any suspicious finding, when inconclusive exams were counted negative, sensitivity was 0.984 (CI .963-.993) and specificity 0.970 (.952-.981); when counted positive, sensitivity was 0.990 (.972-.997) and specificity 0.958 (.938-.971). The packet also summarizes a fully crossed reader study of 14 readers and 200 exams: aided AUC 0.974 versus unaided 0.825, aided mean sensitivity 0.935 versus 0.782, and aided mean specificity 0.970 versus 0.759.
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
- Concurrent CADx aid for suspicious fetal cardiac morphological findings during second-trimester fetal heart ultrasound.
- Intended users
- Interpreting physicians.
- Care setting and population
- Second-trimester anatomic fetal ultrasound at 18-24 weeks of gestation for pregnant women aged 18 or older.
- Workflow role
- Concurrent reading aid and adjunct to physician interpretation; it does not replace the physician or other standard-of-care testing.
- Required input
- Fetal cardiac ultrasound video clips containing interpretable four-chamber, left-ventricular-outflow-tract, and right-ventricular-outflow-tract standard views.
- Output and human action
- For each frame, present, absent, or inconclusive status for eight suspicious fetal cardiac findings, plus an overall exam summary; annotated DICOMs are displayed in the user PACS viewer and optionally in a validated third-party interface.
- Limitations
- Not for multiple pregnancies, fetal heterotaxy, or postnatal ultrasound. Inconclusive outputs require scenario-specific handling in performance analysis. The packet states validation only with Fujifilm, GE, Philips, Samsung, and Toshiba ultrasound devices.
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.
Implementation
Questions for IT, informatics, and operations
Use these fields to structure a vendor demo, security review, and implementation estimate.
- Integration
- Cloud-based software outputs annotated DICOMs to the user PACS viewer and optionally a validated third-party user interface; exact products, versions, routing, and current commercial configuration are not established.
- 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
Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Training and support
- Vendor documentation pending
Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Monitoring and change control
- Vendor documentation pending
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 Fetal EchoScan (v1.2); FDA labeling remains controlling for clinical use, limitations, and performance.
exact submission · checked 2026-09-08Evidence
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 standalone testing used 877 second-trimester fetal ultrasound exams from 11 centers, with three pediatric cardiologists providing majority-vote truthing and testing data separate from training. For any suspicious finding, when inconclusive exams were counted negative, sensitivity was 0.984 (CI .963-.993) and specificity 0.970 (.952-.981); when counted positive, sensitivity was 0.990 (.972-.997) and specificity 0.958 (.938-.971). The packet also summarizes a fully crossed reader study of 14 readers and 200 exams: aided AUC 0.974 versus unaided 0.825, aided mean sensitivity 0.935 versus 0.782, and aided mean specificity 0.970 versus 0.759.
- 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
- DesignStand-alone performance and reader study (ACR AI Central category)
- PopulationAdult
- Scopeexact submission
- Tested version1.2
- Samplen=877
- Sites11
- IndependenceIndependence not established
K252294
ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.
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
No public price or quote for the exact K252294 configuration was established in this review.
- Reimbursement and coding
- Not established in reviewed sources
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 K252294. 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.
Buyer worksheet
Open questions to take to the vendor
- Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
- Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
- Verify pricing and total cost: No public price or quote for the exact K252294 configuration was established in this review.
- Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
- Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.
Research record
What has been checked
This audit distinguishes completed source review from fields that have not yet been researched.
Exact FDA record reviewedStatus
2026-09-20Last searched
25Fields reviewed
9Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads
The refreshed discovery snapshot contains no PubMed or ClinicalTrials.gov candidates; no external evidence was promoted. The current discovery snapshot contains 0 PubMed and 0 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, 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
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FDA K252294: Fetal EchoScan (v1.2)
Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation
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Artificial Intelligence-Enabled Medical Devices
Scope: regulatoryIdentity, modalityContext
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Fetal EchoScan (v1.2) model card (K252294)
Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, anatomy, evidenceStudies, implementationCapabilities
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PubMed biomedical literature index
Scope: evidenceDiscovery
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ClinicalTrials.gov study registry
Scope: evidenceDiscovery, studyStatus
-
openFDA Device Recall API
Scope: recallDiscovery, nativeSubmissionMatching
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openFDA exact recall query for K252294
Scope: postmarketSafety
Research history
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K252294 FDA decision
Regulatory record
510(k)
-
Source-review record updated
Research record
fda record reviewed
-
Reader overview source-reviewed
Editorial review
Source-reviewed editorial overlay
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