Home GUDID 03770024341027
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 Code Name IYN System, Imaging, Pulsed Doppler, Ultrasonic IYO System, Imaging, Pulsed Echo, Ultrasonic QIH Automated Radiological Image Processing Software
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology 2 IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology 2 QIH Automated Radiological Image Processing Software Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03770024341027 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03770024341027 03770024341027 3770024341027
GMDN Terms# Term, Definition table Term Definition Obstetrical/gynaecological ultrasound imaging system An 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.
Regulatory Flags# DUNS number 274345745 Device count 1 Lot or batch true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06903053124348 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124355 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124379 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124430 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124461 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124492 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124546 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124560 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124591 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124607 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124614 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124683 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124706 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124720 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124775 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 06903053124829 Diagnostic Ultrasound System Shenzhen Mindray Bio-Medical Electronics Co., Ltd. IYN 2026-06-03 00850050934240 EndoSound® EVS SideBeam 5103 Endosound, Inc. IYO 2026-06-01 00850050934240 EndoSound® EVS SideBeam 5103 Endosound, Inc. IYN 2026-06-01 00850050934257 EndoSound® Coax Transducer Extension Connector (TEC) Endosound, Inc. IYO 2026-06-01 00850050934257 EndoSound® Coax Transducer Extension Connector (TEC) Endosound, Inc. IYN 2026-06-01 00850050934264 EndoSound® EVS SideBeam 5105 (4 pouches) Endosound, Inc. IYO 2026-06-01 00850050934264 EndoSound® EVS SideBeam 5105 (4 pouches) Endosound, Inc. IYN 2026-06-01 04987670105937 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. IYO 2026-06-01 04987670105937 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. IYN 2026-06-01 04987670106194 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. IYO 2026-06-01 04987670106194 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. IYN 2026-06-01 08800013510112 L8-17H Alpinion Medical Systems Co., Ltd. IYO 2026-05-29 08800013510112 L8-17H Alpinion Medical Systems Co., Ltd. IYN 2026-05-29 00198953121382 Voluson GE Ultrasound Korea Ltd. IYO 2026-05-28 00198953121382 Voluson GE Ultrasound Korea Ltd. IYN 2026-05-28