Search Results

The HeartView system is an internet-based application intended for use by nuclear medicine or radiology practitioners and referring physicians for the automated processing, review, quantification, and multidimensional review of nuclear medicine cardiology medical images, and specifically, radionuclides distributed in the body using planar and tomographic short axis images. HeartView may be used in various clinical settings including a hospital, clinic, imaging center, physician office, or remote locations. The HeartView system implements algorithms for automatic quantification of myocardial perfusion single photon emission computerized tomography (SPECT) as well as quantification of ejection fraction, wall motion, and thickening from gated myocardial perfusion SPECT images. Gated results are presented as 3D plots that can be used to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes, including quantitative assessments of cardiac function (e.g., systolic and diastolic function, regional wall thickening, wall motion, transient ischemic dilation, and phase analysis).

The HeartView platform is a comprehensive internet-based application designed to process, review, and automatically perform quantitative analysis of cardiac nuclear medicine procedures. HeartView implements algorithms for automatic quantification of myocardial perfusion SPECT, as well as quantification of ejection fraction, wall motion, and thickening from gated myocardial perfusion SPECT. The algorithm takes short axis slices reconstructed from raw datasets of gated and averaged acquisitions in rest and stress, and operates in multi-dimension (3D), rather than processing individual slices separately. For gated datasets, it processes the dataset as a whole rather than processing each frame separately, which adds additional knowledge to the algorithm for its computations, and allows enforcement of the constraint that the mid-myocardium volume is constant during the whole heart beat cycle.

Adjustable TheraSnore appliance is indicated for the treatment of snoring and mild to moderate obstructive 18 years of age or older.

The Adjustable Therasnore appliance of this submission ("Subject Device") is an intraoral mandibular repositioning device used during sleep to reduce snoring and treat mild to moderate obstructive sleep apnea in adults (OSA). The Subject Device consists of an upper and a lower tray. The trays snap together and lock by means of a locking mechanism. The upper and lower trays snap together by means of four interlocking mechanisms, or railways which allow 1.5 mm incremental adjustments in a forward and backward fashion. The lower tray can be advanced up to a maximum of 10 mm forward relative to the upper tray. The upper tray fits against the upper teeth and the lower tray fits against the lower teeth. The Subject Device when positioned on the teeth with the mandible in a forward position functions as a mandibular repositioner and acts to increase the patient's pharyngeal space which improves their ability to exchange air during sleep. The Subject Device is a boil and bite appliance consisting of an upper tray designed to fit over the teeth of the maxilla and a lower tray that fits to the lower incisors and prevents the tongue and mandible from falling back during sleep. The Subject Device is worn on the maxillary arch and covers the entire maxillary arch. Each tray is made from a hard acrylic material and a soft thermal plastic. The Subject Device is custom fitted for each patient by a doctor or dentist once the appliance is extracted from the heated water, cooled to the touch and the upper and lower trays are soft and pliable. This pliability allows the physician or dentist to fit the appliance to the upper and lower teeth of the patient when the patient pushes the mandible slightly forward into the appropriate position and the upper and lower tray are locked together. After this custom fitting, the Subject Device when in the patient's mouth, repositions the mandible in a slightly protruded forward position for as long as the Subject Device is worn. The appliance is provided to the patient on the same day of the fitting.

The VidiStar PACS & DICOM Viewer Software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The VidiStar PACS & DICOM Viewer Software is comprised of modular software programs that run on standard "off-the-shelf" personal computers, business computers, and servers running standard operating systems. VidiStar PACS & DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from laboratories, which support DICOM standard imaging data and structured reporting transfer(s). The system provides the capability to: organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, perform quantitative measurements, and create DICOM structure reports, all over the Internet. All quantitative data ranges are derived from the clinical experience of laboratories and are included in observation libraries for VidiStar users. VidiStar strongly recommends that users review these ranges with their individual diagnostic needs in mind prior to using the VidiStar PACS & DICOM Viewer Software system for clinical reporting. The VidiStar PACS & DICOM Viewer Software system should not be used for reviewing full-field digital mammograms.

The VidiStar PACS & DICOM Viewer Software System is a picture archiving and communications system software used to process, display, transfer, enable reports, communicate, store and archive digital medical images using Transmission Control Protocol/Internet Protocol (TCP/IP). It supports DICOM structured reports for creating, rendering, storage and archiving.