FETOLY-HEART

GUDID 03770033463000

Fetoly-Heart is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists, and pediatric cardiologists (designated as healthcare professionals i.e. HCPs) to perform fetal ultrasound examinations of the fetal heart in real-time. Fetoly-Heart can be used by HCPs during fetal ultrasound examinations in the second and third trimesters (gestational age window: from 17 to 40 weeks). The software is intended to assist HCPs in the completeness assessment of the fetal heart ultrasound examination in accordance with national and international guidelines.

DIAGNOLY

Ultrasound imaging system application software

• Primary Device ID: 03770033463000
• NIH Device Record Key: b6b6c826-139f-4e69-893e-fc3956a64d7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FETOLY-HEART
• Version Model Number: 1
• Company DUNS: 274279654
• Company Name: DIAGNOLY
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03770033463000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241380

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: 2024-11-04
• Device Publish Date: 2024-10-25

Devices Manufactured by DIAGNOLY

• 03770033463031 - FETOLY: 2025-10-07 FETOLY is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists and ped
• 03770033463024 - FETOLY: 2025-09-23 FETOLY is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists and ped
• 03770033463000 - FETOLY-HEART: 2024-11-04Fetoly-Heart is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists, and pediatric cardiologists (designated as healthcare professionals i.e. HCPs) to perform fetal ultrasound examinations of the fetal heart in real-time. Fetoly-Heart can be used by HCPs during fetal ultrasound examinations in the second and third trimesters (gestational age window: from 17 to 40 weeks). The software is intended to assist HCPs in the completeness assessment of the fetal heart ultrasound examination in accordance with national and international guidelines.
• 03770033463000 - FETOLY-HEART: 2024-11-04 Fetoly-Heart is a software that aims at helping sonographers, obstetricians, radiologists, maternal-fetal medicine specialists,