FDA-cleared K192287
Transpara
Screenpoint Medical B.V.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2019-12-10
Vendor
Screenpoint Medical B.V.
6 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K193229
Transpara
ScreenPoint Medical B.V.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2020-03-05
FDA-cleared K210404
Transpara 1.7.0
ScreenPoint Medical B.V.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2021-06-02
FDA-cleared K221347
Transpara 1.7.2
ScreenPoint Medical B.V.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2022-08-03
FDA-cleared K232096
Transpara Density 1.0.0
Screenpoint Medical B.V.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2023-12-11
FDA-cleared K241831
Transpara (2.1.0)
ScreenPoint Medical B.V.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2024-11-25