FETOLY

Basic Information

• Brand Name: FETOLY
• Primary DI: 03770033463024
• Version / Model: 1
• Company Name: DIAGNOLY
• Labeler DUNS: 274279654
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-15
• Public Version: 2
• Public Version Date: 2026-03-19
• Public Version Status: Update
• Public Device Record Key: 94dbee8e-6f63-447a-93f4-34fd4d19cc91
• Distribution End Date: 2025-09-29

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	892.1550	2
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2
QIH	Automated Radiological Image Processing Software	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40873	Ultrasound imaging system application software	An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03770033463024	GS1