Eu Mdr Eu Md Class 2a On The Market 🇫🇷 France

Sonio Detect

Sonio · 🇫🇷 France
Devices (same UDI-DI)
2
Certificates
0
Countries
4
Notified Bodies
0

Basic Information

Primary DI
03770024341041
Basic UDI-DI Code
3770024341DetectMM
Reference
v2
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market
Manufacturer
Sonio

Additional Description

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 and characteristics of the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images. Sonio Detect is indicated to be used by Healthcare Professionals during (or after) fetal ultrasound examinations to ensure access to quality fetal anatomy ultrasound imaging that is vital for accurate examination throughout the pregnancy.

CND Nomenclature Codes

Code Description
Z12080192 PRENATAL DIAGNOSTIC INSTRUMENTS - MEDICAL DEVICE SOFTWARE

Available In Countries

🇫🇷 France 🇮🇪 Ireland 🇳🇱 Netherlands 🇸🇰 Slovakia

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