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InVision Precision Cardiac Amyloid is an automated machine learning-based decision support system, indicated as a screening tool for adult patients aged 65 years and over undergoing cardiovascular assessment using echocardiography. When utilized by an interpreting physician, this device provides information alerting the physician for referral to confirmatory investigations. InVision Precision Cardiac Amyloid is indicated in adult populations over 65 years of age. Patient management decisions should not be made solely on the results of the InVision Precision Cardiac Amyloid.

The InVision Precision Cardiac Amyloid (InVision PCA) is a Software as a Medical Device (SaMD) machine-learning screening algorithm to identify high suspicion of cardiac amyloidosis from routinely obtained echocardiogram videos. The device assists clinicians in the diagnosis of cardiac amyloidosis. The InVision PCA algorithm uses a machine learning process to identify the presence of cardiac amyloidosis. The device inputs images and videos from echocardiogram studies, and it outputs a report suggestive or not suggestive of cardiac amyloidosis. The device has no physical form and is installed as a third-party application to an institution's PACS system.

In Vision Precision LVEF is used to process previously acquired trans thoracic cardiac ultrasound images, and manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM compliant PACS system to provide an automated estimation of LVEF. This measurement can be used to assist the clinician in a cardiac evaluation. In Vision Precision is indicated for use in patients 22 years and older by sonographers and physicians evaluating cardiac ultrasound.

InVision Precision LVEF is a software as a medical device (SaMD), manufactured by InVision Medical Technology Corporation, intended as an aid in diagnostic review and analysis of echocardiographic data, including the evaluation of left ventricular ejection fraction (LVEF) in cardiovascular ultrasound images in DICOM format. The software interfaces with data files uploaded to a PACS by any ultrasound or data collection equipment. It selects a set of echocardiogram videos of the correct view and generates semi-automatic segmentations of the left ventricle using a machine learning algorithm to form the basis for the calculator of the LVEF output. The analysis results are visualized by the clinician's integrated image view application as adjustable annotations. The user has the option to modify the semi-automatic segmentations suggested by the software. The EF calculation is updated in real-time with the user's modification of the segmentation. A cardiologist can adjust the annotations and the downstream measurement of LVEF prior to finalization.

The MAKO 7 is a hysteroscope accessory, placed through the working channel of a hysteroscope to obtain samples from the fallopian tube for cytological evaluation.

The MAKO 7 is a hysteroscope accessory intended to collect cell samples from the fallopian tube. The device is comprised of a catheter and a handle. The catheter includes a balloon, a shaft (which is made up of a stainless steel tube and a Nylon tube), a sheath (Nylon 12), and a sheath knob (Polycarbonate). The handle includes a drive wheel and an extension tube that is attached to a luer in the handle body. The extension tube attaches to a commercially available inflation device via a commercially available 3-way stopcock. In summary, the physician inserts the MAKO 7 into the working channel of the hysteroscope until the distal tip of the catheter is positioned immediately proximal to the ostium of the fallopian tube. Then, the balloon is advanced into the fallopian tube and cells are collected on its surface. The MAKO 7 is a sterile, single-use device. The device is terminally sterilized using ethylene oxide (EO).

The MAKO Device is a hysteroscope accessory, placed through the working channel of a hysteroscope to obtain samples from the proximal fallopian tube for cytological evaluation.

The MAKO Device is a hysteroscope accessory intended to collect cell samples from the proximal fallopian tube. The device is comprised of a catheter and a handle. The catheter includes a balloon, a shaft (which is made up of a stainless steel tube and a Nylon tube), a sheath (Nylon 12), and a sheath knob (Polycarbonate). The handle includes a drive wheel and an extension tube that is attached to a luer in the handle body. The extension tube attaches to a commercially available inflation device via a commercially available 3-way stopcock.

The 3-CCD Digital Camera System provides medical professionals with video capabilities for diagnostic and surgical procedures.

This device is a 3-CCD Digital Camera System utilized for medical applications. The intended use for this device is identical to that of most contemporary surgical video camera systems and accessories. The 3-CCD Digital Camera System has been designed and manufactured to meet the UL 2601.1, IEC 601-1, CAN/CSA 601.1, and EN 60601 guidelines for electrical safety.