Sonio Detect

GUDID 03770024341041

Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs 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 by Healthcare Professionals HCPs during fetal ultrasound exams for Trimester 1, Trimester 2 and Trimester 3 of the fetus (GA: from 11 weeks to 37 weeks). The software is intended to assist HCPs in assuring during and after their examination that the examination is complete and all images were collected according to their protocol. Sonio Detect receives fetal ultrasound images and clips from the ultrasound machine, that are submitted through the edge software by the performing healthcare professional, in real-time and performs the following: Automatically detect views; Automatically detect anatomical structures within the supported views; Automatically verify quality criteria of the supported views by checking whether they conform to standardized quality criteria

SONIO

Ultrasound imaging system application software

• Primary Device ID: 03770024341041
• NIH Device Record Key: b716b26e-e6cd-4971-9055-bde6826012da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonio Detect
• Version Model Number: 2
• Company DUNS: 274345745
• Company Name: SONIO
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03770024341041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240406

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-21
• Device Publish Date: 2025-01-13

On-Brand Devices [Sonio Detect ]

• 03770024341027: Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN
• 03770024341041: Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN