Sonio Suspect

GUDID 03770024341034

Sonio Suspect is intended to assist interpreting physicians, during or after fetal ultrasound examinations, by automatically identifying and characterizing abnormal fetal ultrasound findings on detected views, using machine learning techniques. The device is intended for use as a concurrent reading aid on acquired images, during and/or after fetal ultrasound examinations. The device provides information on abnormal findings that may be useful in rendering potential diagnosis. Patient management decisions should not be made solely on the results of the Sonio Suspect analysis.

SONIO

Obstetrical/gynaecological ultrasound imaging system

• Primary Device ID: 03770024341034
• NIH Device Record Key: f691bb75-fbcd-4caf-a620-86206e0db065
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonio Suspect
• Version Model Number: 1
• 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: true
• 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	03770024341034 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243614

FDA Product Code

• POK: Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

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: 2025-09-11
• Device Publish Date: 2025-09-03

Devices Manufactured by SONIO

• 03770024341034 - Sonio Suspect: 2025-09-11Sonio Suspect is intended to assist interpreting physicians, during or after fetal ultrasound examinations, by automatically identifying and characterizing abnormal fetal ultrasound findings on detected views, using machine learning techniques. The device is intended for use as a concurrent reading aid on acquired images, during and/or after fetal ultrasound examinations. The device provides information on abnormal findings that may be useful in rendering potential diagnosis. Patient management decisions should not be made solely on the results of the Sonio Suspect analysis.
• 03770024341034 - Sonio Suspect: 2025-09-11 Sonio Suspect is intended to assist interpreting physicians, during or after fetal ultrasound examinations, by automatically ide
• 03770024341072 - Sonio Pro v3: 2025-09-05 Sonio Pro is intended to be used to perform basic image processing and manipulation. It allows users to review fetal ultrasound
• 03770024341041 - Sonio Detect: 2025-01-21 Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs and Fetal surgeons (all thr
• 03770024341027 - Sonio Detect: 2024-02-26 Sonio Detect is a Software as a Service SaaS solution that aims at helping sonographers, OB/GYN MFMs and Fetal surgeons (all thr
• 03770024341010 - Sonio Pro: 2024-01-08 SONIO Pro is intended to be used by healthcare professionals HCP during OB/GYN exams. It is a software connected to the Ultrasou