FDA-cleared K231130

TumorSight Viz

SimBioSys, Inc.

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2023-12-26
FDA-cleared K243189

TumorSight Viz

SimBioSys, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-10-25
FDA-cleared K251766

TumorSight Viz

SimBioSys, Inc.

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2025-07-08