# K250959: BioticsAI

- Pathway: 510(k) (Traditional)
- Applicant: Bioticsai, Inc.
- Decided: Dec 22, 2025 after 266 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.
No later device cites it as a predicate yet.
0 of 130 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.

## Indications for use
BioticsAI is intended to analyze fetal ultrasound images and frames (DICOM instances) using machine learning techniques to automatically detect views, detect anatomical structures within the views and to facilitate quality criteria verification and characteristics of the views. The device is intended for use by Healthcare Professionals as a concurrent reading aid during and after the acquisition and interpretation of fetal ultrasound images.

Source page: https://510kreport.com/device/K250959
Methodology: https://510kreport.com/methodology