FDA-cleared K233687

ECHELON Synergy V10.0

Fujifilm Healthcare Americas Corporation

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2024-05-03
FDA-cleared K243647

Synapse PACS (7.5)

FUJIFILM Healthcare Americas Corporation

Image analysis/processing.

Modality
Mammography/DBT
Anatomy
N/A
Decision
2025-06-30