FETOLY-HEART
Diagnoly
DIAGNOLY
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3033557977 | 3033557977 | DIAGNOLY | 1 | N | 2026-01-01 | Immeuble Terra Mundi 2 Place De Francfort Lyon 3e Arrondissement Rhone FR 69003 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 332651 | 1266196718 | K251368 | FETOLY | IYN | 2025-09-12 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| IYN | 1 | 2025-09-12 |
PMN#
GUDID#
FETOLY - 3
2026-03-18
FETOLY - FETOLY 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 fetal brain and heart in real-time. FETOLY can be used by HCPs during fetal ultrasound examination 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 fetal brain and heart ultrasound examination in accordance with national and international guidelines. FETOLY is also intended to be used to realize biometric measurements of the fetal brain and heart in accordance with national and international guidelines.
2025-09-29
FETOLY - FETOLY 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 fetal brain and heart in real-time. FETOLY can be used by HCPs during fetal ultrasound examination 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 fetal brain and heart ultrasound examination in accordance with national and international guidelines. FETOLY is also intended to be used to realize biometric measurements of the fetal brain and heart in accordance with national and international guidelines.
2025-09-15
FETOLY-HEART - 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.
2024-10-25