Surgical Specialties México, S. de R.L. de C.V. 62-3042G Sharpoint

Medis Suite MRCT is software intended to be used for the visualization and analysis of MR and CT images of the heart and blood vessels. Medis Suite MRCT is intended to support the following visualization functionalities:- cine loop and 2D review- double oblique review- 3D review by means of MIP and volume rendering- 3D reformatting - performing caliper measurements Medis Suite MRCT is also intended to support the following analyses:- cardiac function quantification- MR velocity-encoded flow quantification- anatomy and tissue segmentation - signal intensity analysis for the myocardium and infarct sizing- MR parametric maps (such as T1, T2, T2* relaxation)Medis Suite MRCT is also intended to be used for:- quantification of T2* results in MR images that can be used to characterize iron loading in the heart and the liver- MR velocity-encoded flow quantification of cerebral spinal fluidThese analyses are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing. The results obtained are displayed on top of the images and provided in reports.The analysis results obtained with Medis Suite MRCT are intended for use by cardiologists and radiologists to support clinical decisions concerning the heart and vessels.

ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter settings, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices. This software also processes, display and performs quantitative calculations of LVEF on multigated acquisition blood pool scans (MUGA). ImagenSPECT™ 3.0 is used to quantitate the uptake of 99mTc pyrophosphate in early and late planar and SPECT studies.The ImagenSPECT™ 3.0 system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation. In addition, quarter-counts, half dose and/or half-time scans can be reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction and is equivalent to the predicate ImagenSPECT™ (k152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose).

Dream Sock Software App. The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not intended to provide notification for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only when sufficient data are available for analysis. The notifications and associated data can be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant. The Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment.

The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA System. The patient's pelvis is secured while performing the indicated spinal flexion and extension bending.The dimensions are approximately 40-47” wide (adjustable width), 24” deep, 42-58” tall (adjustable height). Weight is approximately 98 lbs. (44 kg).

Tinted Pearlescent Powder

S2188 NovoTHOR Gen 3.0 Reg

S2190 NovoTHOR Gen 3.0 XL

S2189 NovoTHOR Gen 3.0 Reg PRX

S2186 NovoTHOR Gen 3.0 XL PRX

The Profile-ESP Radiographic Marker is an accessory for use within the Profile-ESP workflow of the VMA System. It can facilitate the conversion of measurement data by the Profile-ESP software to mm units, and facilitates stitching of spinal x-rays as part of the Image Processing service. The marker is placed around the neck of the patient by the medical imaging professional during x-ray imaging. It is shipped by Company personnel to the customer site and includes a user manual in the device package. No additional training or installation is required.Length – approximately 36” / Weight – approximately 5 oz.

Medis Suite MRCT is software intended to be used for the visualization and analysis of MR and CT images of the heart and blood vessels. Medis Suite MRCT is intended to support the following visualization functionalities:- cine loop and 2D review- double oblique review- 3D review by means of MIP and volume rendering- 3D reformatting - performing caliper measurements Medis Suite MRCT is also intended to support the following analyses:- cardiac function quantification- MR velocity-encoded flow quantification- anatomy and tissue segmentation - signal intensity analysis for the myocardium and infarct sizing- MR parametric maps (such as T1, T2, T2* relaxation)Medis Suite MRCT is also intended to be used for:- quantification of T2* results in MR images that can be used to characterize iron loading in the heart and the liver- MR velocity-encoded flow quantification of cerebral spinal fluidThese analyses are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing. The results obtained are displayed on top of the images and provided in reports.The analysis results obtained with Medis Suite MRCT are intended for use by cardiologists and radiologists to support clinical decisions concerning the heart and vessels.

ImagenSPECT™ 3.0 is a Windows application which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion SPECT images. The system processes gated and ungated SPECT cardiac images to create 3D tomographic data. The user can correct for patient motion, change filter settings, change reconstruction settings, range of reconstruction, and reorientation angles. The application also models the influence of distance dependent blur. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices. This software also processes, display and performs quantitative calculations of LVEF on multigated acquisition blood pool scans (MUGA). ImagenSPECT™ 3.0 is used to quantitate the uptake of 99mTc pyrophosphate in early and late planar and SPECT studies.The ImagenSPECT™ 3.0 system is designed to take nuclear medicine data from commercially available SPECT systems and process the data into a format that can be visualized by a separate computer program or workstation. In addition, quarter-counts, half dose and/or half-time scans can be reconstructed with ImagenSPECT™ 3.0 using resolution recovery, iterative reconstruction and is equivalent to the predicate ImagenSPECT™ (k152503) using half-counts and full counts (full-time scan, half dose/ half-time, full dose).

Dream Sock Software App. The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not intended to provide notification for every episode of the unexpected occurrences of elevated or depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only when sufficient data are available for analysis. The notifications and associated data can be used to supplement the decision by caregivers to seek additional guidance for medical care of the infant. The Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment.

The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA System. The patient's pelvis is secured while performing the indicated spinal flexion and extension bending.The dimensions are approximately 40-47” wide (adjustable width), 24” deep, 42-58” tall (adjustable height). Weight is approximately 98 lbs. (44 kg).