Densitas, Inc. radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K192973

densitas densityai

Densitas, Inc.

Authorized purpose: Provides an ACR BI-RADS 5th Edition breast-density category from compatible full-field digital mammography and DBT as adjunctive information, not a diagnostic aid.

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2020-02-19

Breast imaging

FDA-cleared K170540

DM-Density is a software application intended for use with compatible full field digital mammography systems. DMDensity calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. DM-Density provides these numerical values for each breast as well as a density category to aid interpreting physicians in the assessment of breast tissue composition. DM-Density produces adjunctive information. It is not a diagnostic aid.

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2018-02-23

Breast imaging