FDA-cleared K201632

TOMTEC-ARENA

TOMTEC Imaging Systems GmbH

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2020-08-14
FDA-cleared K213544

TOMTEC-ARENA

TOMTEC Imaging Systems GmbH

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2022-01-06