iCAD ProFound vs Lunit INSIGHT MMG / DBT

Side-by-side compliance facts for two tools ranked in mammography / dbt detection. Every fact links to its source on the tool pages.

iCAD ProFound AI

iCAD

Breast AI for 2D mammography and DBT detection and density.

FDA: 510(k) cleared

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Lunit INSIGHT MMG / DBT AI

Lunit

Mammography and tomosynthesis detection AI.

FDA: 510(k) cleared

Visit site ↗

Tool	FDA	HIPAA	BAA	SOC 2	HITRUST	Epic	Pricing
iCAD ProFound AI	510(k) cleared (K240417)	Unverified	Unverified	Unverified	Unverified	Unverified	Contact sales source for iCAD ProFound pricing
Lunit INSIGHT MMG / DBT AI	510(k) cleared (K260320)	Unverified	Unverified	Unverified	Unverified	Unverified	Unverified

Where they rank

Mammography / DBT detection: iCAD ProFound #2, Lunit INSIGHT MMG / DBT #4

Information about software products for healthcare professionals. Not medical advice, not an endorsement. Verify all details with the vendor. We never collect patient information (PHI).