Sonio Pro v3

GUDID 03770024341072

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.

SONIO

Medical image management system

• Primary Device ID: 03770024341072
• NIH Device Record Key: b6cccf39-6d44-4e89-b32d-a80d162d9653
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonio Pro v3
• Version Model Number: 3
• Company DUNS: 274345745
• Company Name: SONIO
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03770024341072 [Primary]

FDA Product Code

• LMD: System, Digital Image Communications, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-05
• Device Publish Date: 2025-08-28

Devices Manufactured by SONIO

• 03770024341034 - Sonio Suspect: 2025-09-11 Sonio Suspect is intended to assist interpreting physicians, during or after fetal ultrasound examinations, by automatically ide
• 03770024341072 - Sonio Pro v3: 2025-09-05Sonio 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.
• 03770024341072 - Sonio Pro v3: 2025-09-05 Sonio Pro is intended to be used to perform basic image processing and manipulation. It allows users to review fetal ultrasound
• 03770024341041 - Sonio Detect: 2025-01-21 Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs and Fetal surgeons (all thr
• 03770024341027 - Sonio Detect: 2024-02-26 Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs and Fetal surgeons (all thr
• 03770024341010 - Sonio Pro: 2024-01-08 SONIO Pro is intended to be used by healthcare professionals HCP during OB/GYN exams. It is a software connected to the Ultrasou