Radiology AI Directory

Vendor

Diagnoly

2 FDA-cleared listings in this directory.

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FDA-cleared K251368

FETOLY

Diagnoly

FETOLY analyzes fetal ultrasound images and sequences to detect labeled fetal brain and heart views, assess image completeness or quality, and provide fetal biometric measurements...

Modality
Ultrasound
Anatomy
Fetal heart and fetal brain
Decision
2025-09-12
Cardiac imagingDetection and CADeQuantification and segmentation
FDA-cleared K241380

FETOLY-HEART

Diagnoly

Concurrent AI reading aid for routine fetal heart ultrasound examinations in second- and third-trimester pregnancies from 17 to 40 weeks, detecting the five recommended fetal...

Modality
Ultrasound
Anatomy
Obstetric fetal heart
Decision
2024-09-11
Cardiac imagingDetection and CADeUltrasound workflow