Peter Brasseler Holdings, LLC 5025487U0 Brasseler USA

04-C0108 4.0MM ROUND BUR

MR Diffusion Perfusion Mismatch V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software allowing computation of parametric maps from (1) MR Diffusion-weighted imaging (DWI) and (2) MR Perfusion-weighted imaging (PWI) and extraction of volumes of interest based on numerical thresholds applied to the aforementioned maps. Computation of mismatch between extracted volumes is automatically provided.The device is intended to assist trained radiologists and surgeons in the imaging assessment workflow by extraction and communication of metrics from MR Diffusion-weighted imaging (DWI) and MR Perfusion-weighted imaging (PWI).The results of MR Diffusion Perfusion Mismatch V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinician in the medical imaging assessment.MR Diffusion Perfusion Mismatch V1.0 can be integrated and deployed through technical platforms.

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.

Automation Platform V1.5 is a medical image communications device that provides electronic transfer of medical image data between medical devices. Automation Platform V1.5 stores, converts formats and displays medical device data.Automation Platform V1.5 allows the integration of separately registered or cleared processing applications owned by Olea Medical or third parties. These applications are not part of the platform itself.Automation Platform V1.5 allows routing DICOM-compliant and non-DICOM-compliant image data to and from integrated processing applications. For DICOM-compliant image data, Automation Platform V1.5 reads DICOM tags and pixel data to label images.Automation Platform V1.5 allows the integrated processing applications to provide a notification or a flag intended to the user about the status of its outputs.Automation Platform V1.5 provides a simple image software review functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan.Automation Platform V1.5 is intended to be used by trained professionals. Automation Platform V1.5 is not intended for primary diagnosis, detailed treatment planning or treatment of patients and shall not be used to take decisions with diagnosis or therapeutic purposes.

scaled suction jar 2L with lid, sterilizable

scaled suction jar 4L with lid, sterilizable

04-C0108 4.0MM ROUND BUR

MR Diffusion Perfusion Mismatch V1.0 is an automatic calculation tool indicated for use in radiology. The device is an image processing software allowing computation of parametric maps from (1) MR Diffusion-weighted imaging (DWI) and (2) MR Perfusion-weighted imaging (PWI) and extraction of volumes of interest based on numerical thresholds applied to the aforementioned maps. Computation of mismatch between extracted volumes is automatically provided.The device is intended to assist trained radiologists and surgeons in the imaging assessment workflow by extraction and communication of metrics from MR Diffusion-weighted imaging (DWI) and MR Perfusion-weighted imaging (PWI).The results of MR Diffusion Perfusion Mismatch V1.0 are intended to be used in conjunction with other patient information and, based on professional judgment, to assist the clinician in the medical imaging assessment.MR Diffusion Perfusion Mismatch V1.0 can be integrated and deployed through technical platforms.

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.

Automation Platform V1.5 is a medical image communications device that provides electronic transfer of medical image data between medical devices. Automation Platform V1.5 stores, converts formats and displays medical device data.Automation Platform V1.5 allows the integration of separately registered or cleared processing applications owned by Olea Medical or third parties. These applications are not part of the platform itself.Automation Platform V1.5 allows routing DICOM-compliant and non-DICOM-compliant image data to and from integrated processing applications. For DICOM-compliant image data, Automation Platform V1.5 reads DICOM tags and pixel data to label images.Automation Platform V1.5 allows the integrated processing applications to provide a notification or a flag intended to the user about the status of its outputs.Automation Platform V1.5 provides a simple image software review functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan.Automation Platform V1.5 is intended to be used by trained professionals. Automation Platform V1.5 is not intended for primary diagnosis, detailed treatment planning or treatment of patients and shall not be used to take decisions with diagnosis or therapeutic purposes.