# K243614: Sonio Suspect

- Pathway: 510(k) (Traditional)
- Applicant: Sonio
- Decided: Feb 21, 2025 after 91 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: 9 generations back to K913770 (1991). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212616: Koios DS, Koios Medical, Inc. (2021) Summary page 5.

## Most influential descendants
- K261519: Sonio Suspect (2026), 0 descendants of its own

## Indications for use
Sonio Suspect is intended to assist interpreting physicians, during or after fetal ultrasound examinations, by automatically identifying and characterizing abnormal fetal ultrasound findings on detected views, using machine learning techniques. The device is intended for use as a concurrent reading aid on acquired images, during and/or after fetal ultrasound examinations. The device provides information on abnormal findings that may be useful in rendering potential diagnosis. Patient management decisions should not be made solely on the results of the Sonio Suspect analysis.

Source page: https://510kreport.com/device/K243614
Methodology: https://510kreport.com/methodology