Radiology AI Directory

FDA-cleared profile

BrightHeart View Classifier

BrightHeart

Authorized purpose: Automatic standard-view detection and frame extraction to support acquisition and interpretation of second- or third-trimester fetal heart ultrasound.

Cardiac imagingDetection and CADeUltrasound 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 detection and frame extraction to support acquisition and interpretation of second- or third-trimester fetal heart ultrasound.

Overview status: Source-reviewed overview

Clinical takeaway

Clinical role: Automatic standard-view detection and frame extraction to support acquisition and interpretation of second- or third-trimester fetal heart ultrasound.

Evidence takeaway

Evidence from the reviewed source record: The exact FDA performance set contained 2,290 clinically acquired images and video frames from 579 fetal ultrasound examinations at 8 centers; mean standard-view recognition sensitivity was 0.939 and specificity was 0.984.

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 detection and frame extraction to support acquisition and interpretation of second- or third-trimester fetal heart ultrasound.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Intended users
Qualified and trained sonographers, maternal-fetal medicine specialists, obstetricians, gynecologists and fetal surgeons.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Care setting and population
Fetal anatomic ultrasound examinations in the second or third trimester using transabdominal probes.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Workflow role
Adjunct to fetal ultrasound acquisition and interpretation; it classifies standard views and is not a replacement for the interpreting clinician.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Required input
Fetal 2D ultrasound images and video clips from transabdominal examinations at 18 weeks of gestation or later.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Output and human action
Automatic classification of fetal cardiac standard views and automatically extracted example frames for review and documentation.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Limitations
The exact FDA validation used GE, Philips, Samsung and Siemens ultrasound devices and pregnancies at 18 weeks or later recorded with transabdominal probes; performance was lower or less certain in some small demographic subgroups.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06

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
K243684
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
Ultrasound
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Anatomy
Obstetric/Fetal
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2025-05-07
  • 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 current BrightHeart family platform describes a standalone fetal-heart workflow with support for major ultrasound manufacturers, a cart-side tablet option, and results linked into reporting and a web view; exact K243684 interfaces are not established.
  • Public source
  • Product family
  • Checked 2026-09-07
Deployment and data flow
The FDA materials describe a cloud-based, software-only workflow with qualified users reviewing fetal ultrasound images or clips.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-07

No current exact-release security attestation was established.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Training, onboarding, competency, and support commitments are commercial implementation details that require current vendor documentation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-08-13

Local acceptance testing, production monitoring, drift review, update control, and incident escalation require a current vendor and site-specific governance plan.

Automatic view and frame workflow

The exact device classifies standard fetal cardiac views and extracts example frames for review.

exact submission · checked 2026-09-06
Source

Family reporting integration

BrightHeart family material describes results linked into reporting and a standalone web view; exact K243684 integration details are not established.

product family · checked 2026-09-07
Source

Supported ultrasound ecosystem

The exact validation covered GE, Philips, Samsung and Siemens devices; current family material separately describes integration with major manufacturers.

exact submission · checked 2026-09-06
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
The exact FDA performance set contained 2,290 clinically acquired images and video frames from 579 fetal ultrasound examinations at 8 centers; mean standard-view recognition sensitivity was 0.939 and specificity was 0.984.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-06
Reported sensitivity
0.939 (95% CI, 0.917 ; 0.960)
  • 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
0.984 (95% CI, 0.973 ; 0.996)
  • 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.

Mean standard-view recognition sensitivity

0.939 proportion

  • EndpointStandard-view recognition
  • Population2,290 images and video frames from 579 fetal ultrasound examinations at 8 centers
  • Tested versionBrightHeart View Classifier release reviewed in K243684
Source

Mean standard-view recognition specificity

0.984 proportion

  • EndpointStandard-view recognition
  • Population2,290 images and video frames from 579 fetal ultrasound examinations at 8 centers
  • Tested versionBrightHeart View Classifier release reviewed in K243684
Source

BrightHeart View Classifier standard-view recognition validation

  • DesignRetrospective performance validation with stratified subgroup analysis
  • PopulationClinically acquired fetal ultrasound images and video frames from transabdominal examinations at 18 weeks of gestation or later
  • Scopeexact submission
  • Tested versionBrightHeart View Classifier release reviewed in K243684
  • Samplen=579
  • Sites8
  • IndependenceSponsor or vendor study

K243684 FDA 510(k) summary

The sample comprised 2,290 images and frames; the exact labeling limits use to the validated ultrasound vendors and examination conditions.

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
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-07

No numeric price was published in the reviewed sources.

Reimbursement and coding
Research pending
  • Needs research
  • Exact FDA submission
  • Checked 2026-08-31

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
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-04

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

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Human reviewedStatus
2026-09-07Last searched
24Fields reviewed
11Source classes checked
0Screened PubMed leads
0Screened trial leads
0Unreviewed FDA recall leads

The stored candidate metadata contained empty PubMed and clinical-trial ID arrays; metadata was screened, not full-text or registry-reviewed. The stored recall candidate record was empty and no event 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, vendor product page, vendor manual, peer reviewed publication, clinical trial registry, recall database, 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. K243684 FDA decision source

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, purpose, modality, anatomy

  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 (K243684)

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

    Scope: intendedUsers, careSetting, reportedSensitivity, reportedSpecificity, 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. FDA 510(k) decision record and summary reviewed for BrightHeart View Classifier, K243684

    U.S. Food and Drug Administration - Published 2025-05-07 - Accessed 2026-09-06

    Scope: identity, intended_use, performance, limitations, implementation

  8. B-Right AI Platform

    BrightHeart - Accessed 2026-09-07

    Scope: product_family, standard_view_workflow, ultrasound_integration, reporting

Research history

  1. K243684 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    human reviewed

  3. Reader overview source-reviewed

    Editorial review

    Source-reviewed editorial overlay

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