FDA-cleared K203103
Synapse 3D, Synapse 3D Base Tools v6.1
Fujifilm Corporation
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2021-02-09
Vendor
Fujifilm Corporation
4 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K250370
SCENARIA View Phase 5.0
FUJIFILM Corporation
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-05-20
FDA-cleared K243762
Synapse 3D Base Tools (V7.0)
FUJIFILM Corporation
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2025-05-21
FDA-cleared K251386
ECHELON Synergy
Fujifilm Corporation
Image analysis/processing.
- Modality
- MRI
- Anatomy
- N/A
- Decision
- 2025-09-17