RUMEX INTERNATIONAL CORP. 13-149 Rumex

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.

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.

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.

Tinted Pearlescent Powder

Fuse version 1.00

Glaucoma Module 1.00 is a software application intended for the management, display and analysis of visual field and optical coherence tomography data.

Phaco Hook (Overall Length: 123 mm) Titanium

CERTIFIED DRUG FREE URINE 100 ML

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.

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.

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.