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FDA-cleared K241831

Transpara (2.1.0)

ScreenPoint Medical B.V.

Authorized purpose: Transpara 2.1.0 is a concurrent reading aid for physicians interpreting screening full-field digital mammography and digital breast tomosynthesis, providing region and examination scores to support review of suspicious breast findings.

Modality
Mammography/DBT
Anatomy
Breast; regions suspicious for cancer on screening mammography and digital breast tomosynthesis
Decision
2024-11-25
FDA-cleared K232096

Transpara Density 1.0.0

Screenpoint Medical B.V.

Authorized purpose: Automatically determine volumetric breast density, breast volume, and an ACR BI-RADS 5th Edition breast-density category from compatible digital mammography and digital breast tomosynthesis data to aid healthcare professionals in assessing breast tissue composition; it is not a diagnostic aid.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2023-12-11
FDA-cleared K221347

Transpara 1.7.2

ScreenPoint Medical B.V.

Authorized purpose: Concurrent reading aid for physicians interpreting screening FFDM/DBT to identify suspicious breast regions and estimate malignancy likelihood.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2022-08-03
FDA-cleared K210404

Transpara 1.7.0

ScreenPoint Medical B.V.

Authorized purpose: Concurrent reading aid for physicians interpreting screening FFDM and DBT to identify suspicious regions and assess malignancy likelihood.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2021-06-02
FDA-cleared K193229

Transpara

ScreenPoint Medical B.V.

Authorized purpose: Transpara version 1.6 is a concurrent screening aid for FFDM and DBT that presents suspicious-region marks, region scores from 0 to 100, and an exam score from 1 to 10 for physician review.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2020-03-05
FDA-cleared K192287

Transpara

Screenpoint Medical B.V.

Authorized purpose: Transpara version 1.5 is a concurrent screening full-field digital mammography aid that presents suspicious-region marks and scores for physician review and cannot be used as the sole basis for interpretation.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2019-12-10