FDA | Breast | FFDM | Amplifier Integrator

Description of use

cmTriage is a notification-only, parallel-workflow software tool used to identify specific patients to a radiologist in parallel to standard of care image interpretation of 2D FFDM screening mammograms. cmTriage uses an artificial intelligence algorithm to analyze images and flags those, via notification to the Picture Archiving and Communication System (PACS), that have the presence of at least one suspicious finding at the exam level. Notified interpreting physicians are responsible for reviewing each exam on a diagnostic viewer according to the current standard of care. cmTriage is limited to the categorization of exams, does not provide any markings, and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.

The application content is provided by the respective AI vendors.