FDA.reportPublic FDA data

Sonio Pro

Primary DI
03770024341010
Brand
Sonio Pro
Company
SONIO
Model
2
Device description
SONIO Pro is intended to be used by healthcare professionals HCP during OB/GYN exams. It is a softwareconnected to the Ultrasound equipment through a Sonio Edge Software installed in the HCP network that cansend and upload media sent by the Ultrasound equipments in DICOM format, act as a Worklist for thoseUltrasound equipments as well as interact with the IT solutions of the HCP through HL7 protocol(interoperability with the EMR, Billing System, ...) .
Published
2023-12-31
Public version status
Update
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
03770024341010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770024341010037700243410103770024341010

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
274345745
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770024341034Sonio Suspect12025-09-03
03770024341027Sonio Detect 12024-02-16
03770024341072Sonio Pro v332025-08-28
03770024341041Sonio Detect 22025-01-13

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