breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software package cleared under K152602. It is intended to be used by trained breast imaging physicians and trained MRI technologists. breastscape V1.0 includes 2 software modules : - BreastApp supports the visualization, analysis, and reporting of lesions measurements and analysis. - BreastLoc to assist users in planning MR guided breast interventional procedures. Data and images are acquired through DICOM compliant imaging devices and modalities.
A software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.