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Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software package. It is intended to be used by trained professionals including, but not limited to, physicians, MR technicians, radiographers. Functional MR V1.0 includes a software module that computes the activation map from a BOLD sequence and supports the visualization, analysis of activation maps. Functional MR V1.0 can also be used to provide reproducible measurements of derived maps. These measurements include thresholds modification and ROI analysis. Functional MR V1.0 may also be used as an image viewer of multi-modality digital images, including BOLD and DTI images. When interpreted by a skilled physician, Functional MR V1.0 provides information that may be used in a clinically useful context. Patient management decisions should not be based solely on the results of Functional MR V1.0.

The functional MRI technique consists of analyzing the blood-oxygen-level dependent (BOLD) contrast images. This is a type of specialized brain and body scan is used to map neural activity in the brain or spinal cord of humans by imaging the change in blood flow (hemodynamic response) related to energy use by brain cells. Olea Medical proposes the Functional MR V1.0 as an optional medical viewing, analysis and processing, Picture Archiving Communications System (PACS) software module that is intended for use with the Olea Sphere® V3.0 software package (K152602). Functional MR V1.0 software application runs on a standard "off-the-shelf" PC workstation.