BrightHeart View Classifier
K251456BrightHeart · cleared 2025-06-05 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“BrightHeart View Classifier is a cloud-based software-only device which uses artificial intelligence (AI) to detect standard views during fetal heart scanning in fetal ultrasound images and video clips.”
Algorithmneural network using artificial intelligence
source quote (p.5)
“BrightHeart View Classifier is a cloud-based software-only device which uses artificial intelligence (AI) to detect standard views during fetal heart scanning in fetal ultrasound images and video clips. The BrightHeart View Classifier device is powered by a neural network performing standard view classification in fetal ultrasound images.”
Adaptive (vs locked)Yes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Modifications to the BrightHeart View Classifier device will be made in accordance with its Predetermined Change Control Plan (PCCP). The PCCP provides a description of the device's planned modifications, as well as procedures to implement, evaluate and deploy the modifications. These procedures ensure the continued safety and effectiveness of the device, mitigating risks associated with modifications to the BrightHeart View Classifier neural network to not adversely impact the device's performance, safety, or effectiveness associated with its indications for use, and an impact assessment of the planned modifications. Modification of training and/or validation datasets to update model weights and detection thresholds Re-training of the BrightHeart View Classifier with new data to optimize its performance followed by performance testing and a comparison of the original BrightHeart View Classifier to the modified BrightHeart View Classifier (using performance metrics) and verification and validation.”
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedYes
source quote (p.7)
“Cybersecurity documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".”
Validation studies (1)
Retrospective clinical
n=2,290 images · 8 site(s)
endpoints: standard view recognition sensitivity; standard view recognition specificity
standards: IEC 62304:2016
Reported performance (2 observations)
sensitivity0.939CI 95% CI, 0.917 ; 0.960
source quote (p.8)
“The performance testing demonstrated that BrightHeart View Classifier identifies standard views with a mean standard view recognition sensitivity of 0.939 (95% CI, 0.917 ; 0.960) and a mean standard view recognition specificity of 0.984 (95% CI, 0.973 ; 0.996).”
specificity0.984CI 95% CI, 0.973 ; 0.996
source quote (p.8)
“The performance testing demonstrated that BrightHeart View Classifier identifies standard views with a mean standard view recognition sensitivity of 0.939 (95% CI, 0.917 ; 0.960) and a mean standard view recognition specificity of 0.984 (95% CI, 0.973 ; 0.996).”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).