Sonio Pro v3

Primary DI
03770024341072
Brand
Sonio Pro v3
Company
SONIO
Model
3
Device description
Sonio Pro is intended to be used to perform basic image processing and manipulation. It allows usersto review fetal ultrasound images, perform image manipulation and automatically generateexamination 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 donot.Sonio Pro is indicated to be used by healthcare professionals during and/or after the performance offetal ultrasound examination to ensure exam completeness, which is crucial for accurate ultrasoundexamination throughout the pregnancy.
Published
2025-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770024341072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770024341072037700243410723770024341072

GMDN Terms#

Term, Definition table
TermDefinition
Medical image management systemA 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)].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
274345745
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770024341034Sonio Suspect12025-09-03
03770024341027Sonio Detect 12024-02-16
03770024341041Sonio Detect 22025-01-13
03770024341010Sonio Pro 22023-12-31

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