FDA-cleared K192854
MammoScreen
Therapixel
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2020-03-25
Vendor
Therapixel
6 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K211541
MammoScreen 2.0
Therapixel
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2021-11-26
FDA-cleared K240301
MammoScreen® (3)
Therapixel
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2024-08-01
FDA-cleared K241561
MammoScreen BD
Therapixel
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2024-10-02
FDA-cleared K243679
MammoScreen® (4)
Therapixel
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2025-07-03
FDA-cleared K243685
MammoScreen BD
Therapixel
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2025-08-22