# K241380: Fetoly-Heart

- Pathway: 510(k) (Traditional)
- Applicant: Diagnoly
- Decided: Sep 11, 2024 after 119 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K935595 (1995). 129 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240406: Sonio Detect, Sonio (2024) Summary page 5.

## Most influential descendants
- K251368: Fetoly (2025), 0 descendants of its own

## Indications for use
Fetoly-Heart is intended to analyze fetal ultrasound image sequences using machine learning techniques to automatically detect heart views and quality criteria within the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images. Fetoly-Heart is indicated for use during routine fetal heart examination of 2nd and 3rd trimester pregnancy (gestational age: from 17 to 40 weeks).

Source page: https://510kreport.com/device/K241380
Methodology: https://510kreport.com/methodology