Fetal EchoScan (v1.2)
K252294Brightheart · cleared 2025-12-08 · product code POK · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.6)
“Device Type SaMD”
Algorithmneural networks
source quote (p.5)
“Fetal EchoScan is a cloud-based software-only device which uses neural networks to detect suspicious cardiac radiographic findings for further review by trained and qualified physicians.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.8)
“Cybersecurity documentation and testing was conducted as recommended by FDA’s Guidance for Industry and FDA Staff, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”.”
Validation studies (2)
Standalone
n=877 other · 11 site(s)
endpoints: sensitivity; specificity; conclusive output rate
standards: IEC 62304:2016
Reader study (MRMC)
n=200 other
endpoints: ROC AUC; sensitivity; specificity
Reported performance (3 observations)
sensitivity0.935CI 0.892-0.978
source quote (p.11)
“The mean sensitivity for identification of any claimed suspicious finding was 0.935 (0.892-0.978) in the aided reading condition”
specificity0.97CI 0.949-0.991
source quote (p.11)
“The mean specificity for identification of any claimed suspicious finding was 0.970 (0.949-0.991) in the aided reading condition”
aurocas written: “auc”0.974CI 0.957-0.990
source quote (p.11)
“Any suspicious findings 0.974 (0.957 ; 0.990)”
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
0
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).