Volpara Health Technologies Limited radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K211279

Volpara Imaging Software

Volpara Health Technologies Limited

Authorized purpose: Provides volumetric breast density, BI-RADS fourth- or fifth-edition density categories and dose/pressure quality metrics from raw mammography or DBT data as adjunctive information for an MQSA-qualified physician's breast-composition assessment.

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2021-07-27

Breast imaging

FDA-cleared K182310

Volpara Imaging Software

Volpara Health Technologies Limited

Authorized purpose: Volpara Imaging Software processes raw digital breast X-ray and tomosynthesis data to calculate breast-density maps, volumetric density, and a BI-RADS density category as an adjunct to qualified physician interpretation.

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2018-09-21

Breast imaging