Radiology AI Directory

FDA-cleared profile

BrightHeart View Classifier

BrightHeart

Authorized purpose: Automatic standard-view classification, frame extraction, and acquisition-protocol assessment during second- or third-trimester fetal ultrasound.

Cardiac imagingUltrasound 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.

Product overview

Start with the essentials

Authorized purpose: Automatic standard-view classification, frame extraction, and acquisition-protocol assessment during second- or third-trimester fetal ultrasound.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Automatic standard-view classification, frame extraction, and acquisition-protocol assessment during second- or third-trimester fetal ultrasound.

Evidence takeaway

Evidence from the reviewed source record: FDA bench validation used 2,290 clinically acquired images and video frames from 579 fetal ultrasound examinations at 18 weeks of gestation or later, from eight centers. A sonographer and an MFM specialist independently established the standard-view reference. Mean standard-view recognition sensitivity was 0.939 (95% CI 0.917-0.960) and specificity was 0.984 (95% CI 0.973-0.996). Validation used GE, Philips, Samsung, and Siemens ultrasound devices and separate training and testing examinations.

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
Automatic standard-view classification, frame extraction, and acquisition-protocol assessment during second- or third-trimester fetal ultrasound.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Qualified, trained healthcare professionals in a professional prenatal ultrasound environment, including sonographers, MFMs, OB/GYNs, and fetal surgeons
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Professional prenatal ultrasound imaging environment
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Acquisition and interpretation support: classifies standard views, extracts representative frames, and assesses whether documented views satisfy a center-defined acquisition protocol.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
Fetal 2D ultrasound images and video clips from transabdominal probes during second- or third-trimester examinations, at 18 weeks of gestation or later, for pregnant women aged 18 or older and single pregnancies.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Automatic classification of fetal heart and abdomen standard views, extracted example frames from video clips, acquisition-protocol assessment, and annotated DICOM files displayed in a DICOM viewer with optional web-interface display; generated annotated DICOM files cannot be modified by the user.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Not intended for multiple pregnancies. The packet limits intended/validated use to transabdominal examinations at 18 weeks of gestation or later and to General Electric, Philips, Samsung, and Siemens ultrasound devices; standard-view classification is not a disease-detection endpoint.
  • 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
K251456
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Fetal heart and abdomen standard views during fetal anatomic ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-06-05
  • 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
Cloud-based, stand-alone software that operates on DICOM files, displays annotated DICOM outputs in a DICOM viewer, and may also display them in a device web interface. Specific PACS/RIS interfaces and local compatibility are not established.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
On-cloud
  • Public source
  • Exact FDA submission
  • Checked 2026-08-13

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
  • 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 BrightHeart View Classifier; 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 bench validation used 2,290 clinically acquired images and video frames from 579 fetal ultrasound examinations at 18 weeks of gestation or later, from eight centers. A sonographer and an MFM specialist independently established the standard-view reference. Mean standard-view recognition sensitivity was 0.939 (95% CI 0.917-0.960) and specificity was 0.984 (95% CI 0.973-0.996). Validation used GE, Philips, Samsung, and Siemens ultrasound devices and separate training and testing examinations.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
93.9% (95% CI: 91.7%, 96.0%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
98.4% (95% CI: 97.3%, 99.6%)
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

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.

BrightHeart View Classifier regulatory performance study summary

  • DesignStand-Alone Performance
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K251456
  • Samplen=2290
  • Sites8
  • IndependenceIndependence not established

K251456

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 K251456 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 K251456. 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
2026-09-20Last searched
26Fields 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

  1. FDA K251456: BrightHeart View Classifier

    U.S. Food and Drug Administration - Published 2025-06-05 - 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. BrightHeart View Classifier model card (K251456)

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

    Scope: intendedUsers, careSetting, output, limitations, reportedSensitivity, reportedSpecificity, 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 K251456

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

    Scope: postmarketSafety

Research history

  1. K251456 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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