Sonio Pro v3

Basic Information

• Brand Name: Sonio Pro v3
• Primary DI: 03770024341072
• Version / Model: 3
• Company Name: SONIO
• Labeler DUNS: 274345745
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-28
• Public Version: 1
• Public Version Date: 2025-09-05
• Public Version Status: New
• Public Device Record Key: b6cccf39-6d44-4e89-b32d-a80d162d9653

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LMD	System, Digital Image Communications, Radiological	Radiology	892.2020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60723	Medical image management system	A computerized image data management system designed to electronically receive, collect, store, and display a broad range of medical imaging/video data (non-dedicated), and to distribute the data within or between healthcare facilities to facilitate data analysis, organization, reporting, and sharing (e.g., teaching). The system consists of combined hardware (e.g., network switch, controller) and server/client software intended to relay image data from a broad range of imaging/audiovisual devices (e.g., endoscopic camera, ultrasound imaging system, radiography digital imaging system) to off-the-shelf devices [e.g., monitors, personal computers (PC’s)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03770024341072	GS1