Identity
- Trade Name
- Sonio Pro v3 FDA UDI
- Generic Name
- Medical image management system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 3 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03770024341072 FDA UDI
- FDA Product Code
- LMD FDA UDI
- GMDN Term
- Medical image management system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.2020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical image management system
Sonio Pro v3 by Sonio — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical image management system.
- WebPAX® — Heart Imaging Technologies, LLC · Class II
- LiteExam® Station (LES) — GlobalMed Holdings, LLC · Class I
- Optina Fotys — Optina Diagnostiques, Inc · Class I
- Vitegra® — JOIMAX, INC. · Class I
- Amimon — Amimon Inc. · Class I
- Playbook — ORTHOPEDIATRICS CORP. · Class I
- Amimon — Amimon Inc. · Class I
- Vitegra® — JOIMAX, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sonio
Sources (1)
- FDA UDI b6cccf39-6d44-4e89-b32d-a80d162d9653 33 fields · synced May 30, 2026