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…

Registry build 21.09.26

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, …).

6manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (4), Tianjin (1), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LMD
Manufacturer City Province Registered as Device types
Coretronic Projection (Kunshan) Corporation Kunshan Jiangsu Contract manufacturer 3
AUO (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 1
Nanjing Jusha Display Technology Co., Ltd. Nanjing Jiangsu Manufacturer 7
Barco (Suzhou) Healthcare Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 4
Beijing Visual Perception Intelligence Technology Co., Ltd. Tianjin Tianjin Manufacturer 1
E-COM Technology Co., Ltd. Beijing Beijing Manufacturer 1

Record

Regulatory record for Sonio Pro
Listed by Sonio, France
FDA product code LMD
Device type System, Digital Image Communications, Radiological
Device class Class 1
Regulation 21 CFR 892.2020
Establishment Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2023-12-31
Record revised 2024-03-14 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Sonio Pro
Catalogue number Size Status
2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Vitrea Advanced Visualization Canon Medical Informatics, Inc. 34
Barco Barco, Inc 27
RadiForce® Eizo Corporation 23
Vitrea Read Canon Medical Informatics A/S 19
Image Diagnostics, Inc Image Diagnostics, Inc. 19
ScaleOR NDS Surgical Imaging, LLC. 17
interWORKS Avreo, Inc. 16
Vitrea View Canon Medical Informatics, Inc. 14
Clinical review 2MP Barco, Inc 11
Barco Fimi SRL 10
Super Ulstar Durico C&T, Inc. 9
VISIUSmatrix Imris Imaging, Inc. 9

Showing 12 of 193. All products under System, Digital Image Communications, Radiological

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer