Olea Medical USA V1.0 FUNCTIONAL MR

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.

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.

Olea S.I.A. Neurovascular V1.0 is an optional user interface for use on the Olea Medical technical integration platform Olea S.I.A. V1.0 and is designed to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians.Olea S.I.A. Neurovascular V1.0 is intended to:• display MR and CT series and outputs provided by compatible docker applications processing, through the technical integration platform,• allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration platform as inputs to the docker application to reprocess outputs. When available, Olea S.I.A. Neurovascular V1.0 display can be updated with the reprocessed outputs.The information displayed is intended to be used in conjunction with other patient information and based on professional judgment, to assist the clinician in the medical imaging assessment. It is not intended to be used in lieu of the standard care imaging.Trained professionals are responsible for viewing the full set of native images per the standard of care.

CT Perfusion 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 CT Perfusion data 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 be used by trained professionals with medical imaging education including but not limited to, physicians and medical technicians in the imaging assessment workflow by extraction and communication of metrics from CT Perfusion dataset.The results of CT Perfusion 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. Trained professionals are responsible for viewing the full set of native images per the standard of care.CT Perfusion V1.0 can be integrated and deployed through technical platforms.

Manual Refractor is an ophthalmic testing device used to measure an individual’s refractive error and determine their eyeglass prescription.

Disposable Face Mask, Blue, non-sterlie, covering mouth and nose intends to use for protection in general public

Disposable Face Mask, White, non-sterlie, covering mouth and nose intends to use for protection in general public

Maxx Resolve Swing-Away Joystick Mount Assembly. Components/hardware used to mount the Resolve Swing-Away Joystick assembly onto the armrest on a Motion Concepts Power Positioning System. Straight or jogged tube option available. Can be mounted onto Left or Right armrests

MR DWI/FLAIR Measurement V1.0 is an image processing application indicated for use in the analysis of:(1) MR Diffusion-weighted imaging (DWI)(2) MR FLAIR images.The device is intended to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians in the imaging assessment workflow:• computation of the map relative to the water diffusion, i.e., ADC map;• extraction and communication of metrics derived from the above map, i.e., hypointense area on ADC, and FLAIR series as well as ratios with contralateral information on FLAIR images.The results of MR DWI/FLAIR Measurement 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. Trained professionals are responsible for viewing the full set of native images per the standard of care. MR DWI/FLAIR Measurement V1.0 can be integrated and deployed through technical platforms.

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.

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.

Olea S.I.A. Neurovascular V1.0 is an optional user interface for use on the Olea Medical technical integration platform Olea S.I.A. V1.0 and is designed to be used by trained professionals with medical imaging education including, but not limited to, physicians and medical technicians.Olea S.I.A. Neurovascular V1.0 is intended to:• display MR and CT series and outputs provided by compatible docker applications processing, through the technical integration platform,• allow the user to edit and modify parameters that are optional inputs of aforementioned applications. These modified parameters are provided through the technical integration platform as inputs to the docker application to reprocess outputs. When available, Olea S.I.A. Neurovascular V1.0 display can be updated with the reprocessed outputs.The information displayed is intended to be used in conjunction with other patient information and based on professional judgment, to assist the clinician in the medical imaging assessment. It is not intended to be used in lieu of the standard care imaging.Trained professionals are responsible for viewing the full set of native images per the standard of care.

CT Perfusion 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 CT Perfusion data 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 be used by trained professionals with medical imaging education including but not limited to, physicians and medical technicians in the imaging assessment workflow by extraction and communication of metrics from CT Perfusion dataset.The results of CT Perfusion 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. Trained professionals are responsible for viewing the full set of native images per the standard of care.CT Perfusion V1.0 can be integrated and deployed through technical platforms.