BrightHeart View Classifier
K243684BrightHeart · cleared 2025-05-07 · product code QIH · Radiology
Premarket evidence — what FDA accepted
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.”
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.”
source quote (p.9)
“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.”
source quote (p.2)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
source quote (p.8)
“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 classification; standard view recognition sensitivity; standard view recognition specificity
standards: IEC 62304:2016
Reported performance (2 observations)
source quote (p.9)
“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)”
source quote (p.9)
“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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K251456 (decision 2025-06-05) from BrightHeart for a matching device line ("BrightHeart View Classifier") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K251456
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).