Sonio Suspect
Sonio
SONIO
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3029937167 | 3029937167 | SONIO | 1 | N | 2026-01-01 | 147 rue d'Aboukir Paris FR 75002 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 320504 | 1064532876 | K243614 | Sonio Suspect | POK | 2025-02-21 |
| 320504 | 1326779574 | K240406 | Sonio Detect | IYN | 2024-04-26 |
| 320504 | 1783627103 | K230365 | Sonio Detect | IYN | 2023-07-25 |
| 320504 | 1692547343 |
Product Codes Associated With Registrations
PMN
GUDID
Sonio Suspect - 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.
2025-09-03
Sonio Pro v3 - Sonio Pro is intended to be used to perform basic image processing and manipulation. It allows users to review fetal ultrasound images, perform image manipulation and automatically generate examination reports. It can also be used to print and/or share images. Sonio Pro is segregated into several features, some of which serve a medical purpose, while others do not. Sonio Pro is indicated to be used by healthcare professionals during and/or after the performance of fetal ultrasound examination to ensure exam completeness, which is crucial for accurate ultrasound examination throughout the pregnancy.
2025-08-28
Sonio Detect - Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP in the following) to perform their routine fetal ultrasound examinations in real-time. Sonio Detect can be used by Healthcare Professionals HCPs during fetal ultrasound exams for Trimester 1, Trimester 2 and Trimester 3 of the fetus (GA: from 11 weeks to 37 weeks). The software is intended to assist HCPs in assuring during and after their examination that the examination is complete and all images were collected according to their protocol. Sonio Detect receives fetal ultrasound images and clips from the ultrasound machine, that are submitted through the edge software by the performing healthcare professional, in real-time and performs the following: Automatically detect views; Automatically detect anatomical structures within the supported views; Automatically verify quality criteria of the supported views by checking whether they conform to standardized quality criteria
2025-01-13
Sonio Detect - Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP in the following) to perform their routine fetal ultrasound examinations in real-time. Sonio Detect can be used by Healthcare Professionals HCPs during fetal ultrasound exams for Trimester 1, Trimester 2 and Trimester 3 of the fetus (GA: from 11 weeks to 37 weeks). The software is intended to assist HCPs in assuring during and after their examination that the examination is complete and all images were collected according to their protocol.
2024-02-16
Sonio Pro - SONIO Pro is intended to be used by healthcare professionals HCP during OB/GYN exams. It is a software connected to the Ultrasound equipment through a Sonio Edge Software installed in the HCP network that can send and upload media sent by the Ultrasound equipments in DICOM format, act as a Worklist for those Ultrasound equipments as well as interact with the IT solutions of the HCP through HL7 protocol (interoperability with the EMR, Billing System, ...) .
2023-12-31