FDA-cleared K213544

TOMTEC-ARENA

TOMTEC Imaging Systems GmbH

TOMTEC-ARENA TTA2.50 analyzes ultrasound to quantify and report cardiovascular, fetal, and abdominal structures and functions, including editable AI-assisted echocardiographic...

Modality
Ultrasound
Anatomy
Heart/Cardiovascular
Decision
2022-01-06
FDA-cleared K201632

TOMTEC-ARENA

TOMTEC Imaging Systems GmbH

TOMTEC-ARENA quantifies and reports cardiovascular, fetal, and abdominal structures and functions from supported clinical images and can exchange data with IMAGE-ARENA and...

Modality
Ultrasound
Anatomy
Heart/Cardiovascular
Decision
2020-08-14