# K251368: Fetoly

- Pathway: 510(k) (Traditional)
- Applicant: Diagnoly
- Decided: Sep 12, 2025 after 134 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: 26 generations back to K935595 (1995). 130 ancestors in all.
No later device cites it as a predicate yet.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241380: Fetoly-Heart, Diagnoly (2024) Summary page 5.

## Indications for use
FETOLY is intended to analyze fetal ultrasound image sequences using machine learning techniques to automatically: • detect brain and heart views and quality criteria within the views; • detect images suitable for measuring biometric parameters of the fetal heart and brain and provide quantitative measurements of these parameters. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images. FETOLY is indicated for use during routine fetal heart and brain examination of 2nd and 3rd trimester pregnancy (gestational age: from 17 to 40 weeks).

Source page: https://510kreport.com/device/K251368
Methodology: https://510kreport.com/methodology