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FDA-cleared K153427

Volpara Imaging Software

Matakina Technology LTD

Authorized purpose: Volpara processes raw data from digital breast x-ray systems, including tomosynthesis, to calculate density maps, volumetric breast density, and BI-RADS breast-density categories as adjunctive information for an MQSA-qualified interpreting physician.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2016-01-07