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FDA-cleared K213544

TOMTEC-ARENA

TOMTEC Imaging Systems GmbH

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

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 third-party applications.

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