Information Security and Medical Device Regulations

United States of America

• Sonio Detect is US FDA 510(k) cleared. 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. The 510(k) summary is publicly available here in FDA’s database.
• Sonio Expert is a non-medical device Clinical Decision Support software. Sonio Expert is a clinical decision support tool intended as an aid for qualified healthcare professionals to analyse and diagnose ultrasound-visible fetal anomalies/diseases and related pathological syndromes during performance of prenatal sonography, in combination with other relevant clinical information and reference guidelines. Patient management decisions should not be made solely on the basis of analysis by Sonio Diagnostics.
• Sonio Pro is US class I medical device and a “medical image communication device”. Sonio Pro is intended to help Healthcare Practitioners to make sure US screening exams are well performed.

European Union (EU)

• Sonio Detect is class IIa medical device according to the EU medical device regulation 2017/745. Sonio Detect CE mark certification is ongoing.
• Sonio Expert (Sonio Diagnostics v2) is CE mark certified and is class IIa medical device according to the EU medical device regulation 2017/745.
• Sonio Pro is not a medical device in EU. Sonio Pro is intended to help Healthcare Practitioners to make sure ultrasound screening exams are well performed.

Other Geographies

Please contact [email protected] for information on Sonio’s device registrations in any country.