HeartFocus (V.1.1.1)

Buyer-fit notes

HeartFocus (V.1.1.1) is best reviewed for Mammography/DBT Heart teams evaluating breast imaging tools with FDA source traceability.

Not ideal for buyers who need public price benchmarks before vendor contact.

FDA and evidence source ledger

• K242807 FDA source
• FDA AI-enabled medical devices list

Clinical use

Image analysis/processing for Heart using Mammography/DBT.