Sonio Pro

GUDID 03770024341010

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, ...) .

SONIO

General-purpose ultrasound imaging system

• Primary Device ID: 03770024341010
• NIH Device Record Key: 72d68234-3919-4426-a8dd-768eb7972f7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonio Pro
• Version Model Number: 2
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03770024341010 [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: 2024-01-08
• Device Publish Date: 2023-12-31

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: 2025-09-05 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: 2024-01-08SONIO 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, ...) .
• 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