This is a prospective, controlled, multi-center, observational international registry designed to evaluate the Imagio breast imaging system. The registry will be conducted at up to 12 international centers. Investigators will use Imagio US (IUS) and/or Imagio OA/US imaging per standard of care, anddata will be collected accordingly. Additional imaging and biopsy/surgery will be conducted per standard of care to reach a final diagnosis.
This registry has been designed to obtain real-life, post-market data on the use of the Imagio breast imaging system. This registry is sponsored by Seno Medical Instruments, Inc., the manufacturer of the device.