# K230365: Sonio Detect

- Pathway: 510(k) (Traditional)
- Applicant: Sonio
- Decided: Jul 25, 2023 after 165 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: 23 generations back to K935595 (1995). 127 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201828: Voluson SWIFT, Voluson SWIFT+, GE Medical Systems Ultrasound and Primary Care Diagnostics (2020) Summary page 5.

## Most influential descendants
- K240406: Sonio Detect (2024), 4 descendants of its own
- K241380: Fetoly-Heart (2024), 1 descendant of its own
- K252433: Sonio Detect  (v3) (2026), 0 descendants of its own
- K250959: BioticsAI (2025), 0 descendants of its own
- K251368: Fetoly (2025), 0 descendants of its own

## Indications for use
Sonio Detect is intended to analyze fetal ultrasound images and clips using machine learning techniques to automatically detect views, detect anatomical structures within the views and verify quality criteria of the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images.

Source page: https://510kreport.com/device/K230365
Methodology: https://510kreport.com/methodology