# K261519: Sonio Suspect

- Pathway: 510(k) (Special)
- Applicant: Sonio
- Decided: Jun 4, 2026 after 28 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: 10 generations back to K913770 (1991). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243614: Sonio Suspect, Sonio (2025) Summary page 5.

## 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/K261519
Methodology: https://510kreport.com/methodology