FDA-cleared K203517
Saige-Q
DeepHealth, Inc.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2021-04-16
Vendor
DeepHealth, Inc.
7 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K220105
Saige-Dx
DeepHealth, Inc.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2022-05-12
FDA-cleared K222275
Saige-Density
DeepHealth, Inc.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2022-12-16
FDA-cleared K241747
Saige-Dx
DeepHealth, Inc
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2024-11-18
FDA-cleared K243688
Saige-Dx (3.1.0)
DeepHealth, Inc.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2024-12-19
FDA-cleared K243705
Saige-Density (2.5.0)
DeepHealth, Inc
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2024-12-19
FDA-cleared K251873
Saige-Dx
DeepHealth, Inc.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2025-08-11