# K251071: Fetal EchoScan (v1.1)

- Pathway: 510(k) (Special)
- Applicant: Brightheart
- Decided: May 2, 2025 after 25 days
- Product code: POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K913770 (1991). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242342: Fetal EchoScan, Brightheart (2024) Summary page 4.

## Most influential descendants
- K252294: Fetal EchoScan (v1.2) (2025), 0 descendants of its own

## Indications for use
Fetal EchoScan is a machine learning-based computer-assisted diagnosis (CADXx) software device indicated as an adjunct to fetal heart ultrasound examination in pregnant women aged 18 or older undergoing second-trimester anatomic ultrasound exams. When utilized by an interpreting physician, Fetal EchoScan provides information regarding the presence of any of the following suspicious radiographic findings: - Overriding artery - Septal defect at the cardiac crux - Abnormal relationship of the outflow tracts - Enlarged cardiothoracic ratio - Right ventricular to left ventricular size discrepancy - Tricuspid valve to mitral valve annular size discrepancy - Pulmonary valve to aortic valve annular size discrepancy - Cardiac axis deviation Fetal EchoScan is to be used with cardiac fetal ultrasound video clips containing interpretable 4-chamber, left ventricular outflow tract, right ventricular outflow tract standard views. Fetal EchoScan is intended for use as a concurrent reading aid for interpreting physicians (OB-GYN, maternal fetal medicine specialists). It does not replace the role of the physician or of other diagnostic testing in the standard of care. When utilized by an interpreting physician, this device provides information that may be useful in rendering an accurate diagnosis regarding the potential presence of morphological abnormalities that might be suggestive of fetal congenital heart defects that may be useful in determining the need for additional exams. Fetal EchoScan is not intended for use in multiple pregnancies, cases of heterotaxy, and postnatal ultrasound exams.

Source page: https://510kreport.com/device/K251071
Methodology: https://510kreport.com/methodology