Disclaimer
Sonio Expert is a non-device Clinical Decision Support CDS software as per FDA guidance on Clinical Decision Support Software issued on September 28, 2022. Sonio Expert may only be used by fetal ultrasounds professionals and complements their expertise. The consultation of general terms of use on sonio.ai is mandatory prior to use. Manufacturer SONIO SAS – Advertising established in 2022.
Sonio Pro is a non-device-MDDS as per FDA guidance on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices, issued on September 28, 2022. Sonio Pro may only be used by fetal ultrasound professionals and complements their expertise. The consultation of general terms of use on sonio.ai is mandatory prior to use. Manufacturer SONIO SAS – Advertising established in 2022.
Sonio Detect is FDA 510(k) pending.