Sonio Detect

Primary DI
03770024341027
Brand
Sonio Detect
Company
SONIO
Model
1
Device description
Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYNMFMs and Fetal surgeons (all three designated as healthcare professionals i.e. HCP in the following)to perform their routine fetal ultrasound examinations in real-time. Sonio Detect can be used byHealthcare Professionals HCPs during fetal ultrasound exams for Trimester 1, Trimester 2 andTrimester 3 of the fetus (GA: from 11 weeks to 37 weeks). The software is intended to assist HCPs inassuring during and after their examination that the examination is complete and all images werecollected according to their protocol.
Published
2024-02-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230365000Sonio DetectSonio2023-07-25IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770024341027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770024341027037700243410273770024341027

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological ultrasound imaging systemAn assembly of mains electricity (AC-powered) devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) obstetrical and gynaecological (OB/GYN) imaging procedures. It includes software packages to support a variety of static and real-time OB/GYN imaging applications involving foetal imaging, amniocentesis procedures and uterine imaging. The system generates ultrasound pulses, directs them to the target area, detects the ultrasound echoes, and processes the resulting information to produce and display static or dynamic two- or three-dimensional (3-D) images of human anatomy. It is also used to guide and confirm placement of other medical instruments in use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
274345745
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770024341034Sonio Suspect12025-09-03
03770024341072Sonio Pro v332025-08-28
03770024341041Sonio Detect 22025-01-13
03770024341010Sonio Pro 22023-12-31

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