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Dri-Scope Aid-Cabinet; Pump Wall; Series 1840; DSAC-PW2-MOB; TRICOR Label; Dri-Scope Aid - Cabinet system is intended to aid in drying and venting internal channels of cleaned and disinfected endoscopes. The system is designed to cost-effectively convert existing passive cabinets (or closets) to active drying cabinets (or closets). The system can process as many as 16 endoscopes that are waiting in the queue. It provides pressure sensitive continuous flow of clean HEPA filtered air. Simply attach the endoscope, press the button to place the endoscope in the processing queue and the system will take care of the rest. After the drying cycle is complete, the system will periodically cycle dry air through the endoscope internal channels on a timed basis indefinitely until the endoscope is removed from the system. This (TRICOR Systems Inc - built / TRICOR Systems Inc - labeled) wall-mounted pump version is one component of the Dri-Scope Aid – Cabinet system that contains an internal pump used to provide HEPA filtered air to other parts of the system. Note: this system has been programmed to accept external software commands and/or remote monitoring via Mobile Aspects proprietary hardware and software.

Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system. The Merge Cardio system is intended to allow authorized health care professionals the ability to import, export, review, analyze, quantify, report and manage digital cardiovascular images, documents, and data related to cardiology. The study list supports workflow management by providing a robust study list with configurable informational columns supporting navigation, current study and reporting status, and prior study availability and relevancy. The system offers standard image controls such as brightness, contrast, zoom, and cine playback controls; as well modality specific tools such as R-wave sync and frame rate sync. The system allows users to review images, annotate images, perform digital subtraction on XA images, perform quantitative measurements on images (based on modality and anatomy including quantitative coronary analysis, left ventricular analysis, distance, angle, velocity, slope, area, velocity time integral, and volume), derive US measurements, and generate clinical reports. The system provides the ability to create clinical reports for Adult Echo, Pediatric Echo, Vascular US, Nuclear Medicine, Cath/Peripheral Invasive, Electrophysiology, Cardiac CT, and Cardiac MR. Merge Cardio runs on standard information technology hardware and software, using standard technology operating systems and user interfaces. Communication and data exchange are done using standard protocols.

Merge Cardio is a software medical device that is an integrated multi-modality image cardiovascular information management system. The Merge Cardio system is intended to allow authorized health care professionals the ability to import, export, review, analyze, quantify, report and manage digital cardiovascular images, documents, and data related to cardiology. The study list supports workflow management by providing a robust study list with configurable informational columns supporting navigation, current study and reporting status, and prior study availability and relevancy. The system offers standard image controls such as brightness, contrast, zoom, and cine playback controls; as well modality specific tools such as R-wave sync and frame rate sync. The system allows users to review images, annotate images, perform digital subtraction on XA images, perform quantitative measurements on images (based on modality and anatomy including quantitative coronary analysis, left ventricular analysis, distance, angle, velocity, slope, area, velocity time integral, and volume), derive US measurements, and generate clinical reports. The system provides the ability to create clinical reports for Adult Echo, Pediatric Echo, Vascular US, Nuclear Medicine, Cath/Peripheral Invasive, Electrophysiology, Cardiac CT, and Cardiac MR. Merge Cardio runs on standard information technology hardware and software, using standard technology operating systems and user interfaces. Communication and data exchange are done using standard protocols.

ORS Visual is a proprietary software application developed by Object Research Systems (ORS) Inc. that can be is used for the display and 3D visualization of medical image data derived from CT, MRI, and other modalities. It provides for the communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data. ORS Visual, which is available in 32 and 64-bit versions, can be installed on a standard personal computer running the Windows operating system with the Microsoft ActiveX component and suitable graphics hardware. Available functions include DICOM communication, display of 2D images in orthogonal and oblique planes, computation and display of rendered 3D images and maximum intensity projections (MIPs), and 2D and 3D image measurements. The user interface follows typical clinical workflow patterns that include searching for patient data, reviewing and analyzing digital images, and reporting findings. The user controls these functions with normal mouse-click conventions, a system of context-based tools, and on-screen prompts. A standard layout for image display, navigation, and information is used throughout the application. ORS Visual also offers users two separate add-on modules to address specific vascular clinical functionalities: Vessel Analysis, an add-on solution for vascular analysis and stent-graft planning of CTA studies, and Autoplaque, a cardiac plaque and lesion quantification tool.

Dri-Scope Aid-Cabinet; Pump Wall BL1; Series 1840; DSAC-PW3-MOB; TRICOR Label; Dri-Scope Aid - Cabinet system is intended to aid in drying and venting internal channels of cleaned and disinfected endoscopes. The system is designed to cost-effectively convert existing passive cabinets (or closets) to active drying cabinets (or closets). The system can process as many as 16 endoscopes that are waiting in the queue. It provides pressure sensitive continuous flow of clean HEPA filtered air. Simply attach the endoscope, press the button to place the endoscope in the processing queue and the system will take care of the rest. After the drying cycle is complete, the system will periodically cycle dry air through the endoscope internal channels on a timed basis indefinitely until the endoscope is removed from the system. This (TRICOR Systems Inc - built / TRICOR Systems Inc - labeled) wall-mounted pump version is one component of the Dri-Scope Aid – Cabinet system that contains an internal pump used to provide HEPA filtered air to other parts of the system. This pump component is used along with 2 (or 1) of the Dri-Scope Aid - Manifolds which together works as a drying system. Note: this system has been programmed to accept external software commands and/or remote monitoring via Mobile Aspects proprietary hardware and software.

The Universal SmartECG is an ECG amplifier that connects to electrodes on a patient and a PC with Windows operating systems via a USB connection. The ECG amplifier detects electrical impulses from the patient and coverts them into a digital signal that can be displayed and recorded on the computer. The ECG system consists of a 12-lead ECG, multi-language Office Medic Software and VectraplexECG, a UL 60950 compliant host computer and accessories. The 12-lead ECG includes an analog front end designed to detect, amplify, filter, and output biopotential measurements in real time, a microprocessor to communicate and control the analog front end and system, short circuit protection, ESD protection, defibrillation isolation and protection, a green indication LED, 10 leadwires, lead off detection, USB communication to PC and Office Medic or VectraplexECG, and bootloader. The device is powered by the USB connector and is regulated to two separate supplies, a 3.3V digital supply and a 3.3V analog supply to respectively power the digital and analog circuitry. The 12-lead ECG outputs ECG waveform information via USB to the Office Medic or VectraplexECG Software that translates, filters, analyzes, and displays the ECG waveform in real time. The hardware contains an FTDI USB UART translator chip to install required USB drivers to the PC and allow appropriate data conversion to the PC during ECG measurement.

EmbryoScope+ consists of the following devices with the following indications for use: The EmbryoScope+ incubator provides an environment with controlled temperature and gas concentrations (CO2 and O2) for the development of embryos at or near body temperature. Use of the EmbryoScope+ incubator is limited to five days (120 hr) covering the time from post insemination to day five of development. The EmbryoSlide+ culture dish is intended for preparing, storing, and transferring human embryos. The EmbryoSlide+ culture dish must be used together with the EmbryoScope+ incubator. The EmbryoViewer software is intended for displaying, comparing, storing, and transferring images generated by the EmbryoScope+ incubator. This software includes a user annotation function for capturing information on embryo development parameters as well as a user-defined modeling function, which allows the user to combine annotated information on embryo development parameters to aid in embryo selection. The EmbryoViewer software does not control any hardware components in the EmbryoScope+ incubator. The ES Server software is intended to store, archive and transfer data. In addition, this software includes functions for managing models and performing calculations based on image data and embryo development parameters. The EmbryoScope+ incubator, EmbryoViewer software, and ES Server software must be used together to export embryo images from the EmbryoScope+ incubator. The EmbryoViewer software and ES Server software must be used together to analyze the embryo images.

Autoplaque is a post-processing add-on module for ORS Visual that provides automated quantification of calcified and non-calcified plaque lesions in coronary arteries from contrasted coronary CT angiographic studies for the evaluation of cardiovascular disease. Users can automatically segment the section of the coronary artery of interest, or manually input the centerline, to initiate a detailed and robust plaque lesion analysis routine. Analysis by Autoplaque provides biometric information that includes calcified plaque volume, non-calcified plaque volume with possible separation into low and high density non-calcified plaques, stenosis percentage, remodeling index, plaque length measurement, and proximal, distal, and stenosis diameters. If the Autoplaque add-on is used to analyze more than one coronary artery section, the additional parameters of total non-calcified plaque volume, total low density plaque volume, total calcified plaque volume, maximum remodeling index, maximum stenosis percentage, and the maximum plaque length will also be available. ORS Visual is a proprietary software application developed by Object Research Systems (ORS) Inc. that can be is used for the display and 3D visualization of medical image data derived from CT, MRI, and other modalities. It provides for the communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data. ORS Visual, which is available in 32 and 64-bit versions, can be installed on a standard personal computer running the Windows operating system with the Microsoft ActiveX component and suitable graphics hardware.

Dri-Scope Aid-Cabinet; Pump Wall BL1; Series 1840; DSAC-PW3-MOB-R; TRICOR Label; Refurbished; Dri-Scope Aid - Cabinet system is intended to aid in drying and venting internal channels of cleaned and disinfected endoscopes. The system is designed to cost-effectively convert existing passive cabinets (or closets) to active drying cabinets (or closets). The system can process as many as 16 endoscopes that are waiting in the queue. It provides pressure sensitive continuous flow of clean HEPA filtered air. Simply attach the endoscope, press the button to place the endoscope in the processing queue and the system will take care of the rest. After the drying cycle is complete, the system will periodically cycle dry air through the endoscope internal channels on a timed basis indefinitely until the endoscope is removed from the system. This (TRICOR Systems Inc - built / TRICOR Systems Inc - labeled) wall-mounted pump version is one component of the Dri-Scope Aid – Cabinet system that contains an internal pump used to provide HEPA filtered air to other parts of the system. This pump component is used along with 2 (or 1) of the Dri-Scope Aid - Manifolds which together works as a drying system. Note: this system has been programmed to accept external software commands and/or remote monitoring via Mobile Aspects proprietary hardware and software. This component has been refurbished to a condition of safety and effectiveness that is comparable to when new.

roclub TeleOperationPlatform (rTOP) is a medical device (including hardware and software) for geographically distant technologist or radiologists to remotely assist with operating imaging equipment and radiotherapeutic devices. rTOP provides a private, secure communication platform for real-time image visualization and cross-organizational collaboration between healthcare professionals across multiple sites. rTOP enables remote access to modality consoles and enhances communication capabilities between healthcare professionals across different locations. It is vendor-neutral and applicable to existing multimodalities in a healthcare network, a solution that allows healthcare professionals to share expertise and increase productivity, even when they are not physically present in the same location. rTOP is based on a client server architecture, with a cloud infrastructure as the backbone and 2 different variants of client, based on the user roles, local operator and remote operator. The remote operator app is a web client which runs in a web browser. The local operator establishes remote connection to the remote operator through the roclub connector (rC) including a video splitter and emulation of mouse and keyboard. The remote operator can establish connections to more than one rC. Additional remote operators can connect for assistance or training purposes. The connection is possible in full control or read-only mode. The access to the system must be granted by the local user using the system. The access to the system can be revoked at any time by the local user, thus allowing the local user full control of the session at all times. The full-control accessibility to higher risk modalities with physical switches (CT scanners) is limited to the software associated with the modality workplace and is not applicable to the physical switches controlling the equipment operation.

AI Metrics is a thin client software application used with general purpose computing hardware for the display and visualization of medical image data, supporting images and anatomical datasets, such as CT and MR. AI Metrics is designed as a workflow automation application with analytical tools to help the user assess, categorize and document the extent of a disease and/or tumor response to therapy in accordance with user selected standards (e.g. RECIST 1.1) and assess changes in imaging findings over multiple time-points. AI Metrics supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and other Medical Imaging environments. AI Metrics functionality provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources, navigation through images, selection of regions of interest, generation of information from those regions, evaluation in accordance with user selected standards, and generation of a structured report. The user controls these functions with a system of interactive menus and semi-automated or manual workflow automation tools, including: • Manual annotation tools for users to select regions of interest (ROIs), • Semi-automatic lesion segmentation suggestions for user-selected ROIs, • Automatic measurement and display of long and short axis of segmented lesions, • Automatic tabulation and summation of measurements, • Semi-automatic lesion labelling suggestions for anatomical location (organ, body region, and laterality), • Automatic calculation of quantitative and qualitative metrics using annotation data in accordance with the selected criteria, and • Automatic generation of a structured report that includes the annotation data and calculated quantitative and qualitative metrics presented in a graph, table, key images, and structured text report.

The nCommand Lite system is a SaMD (Software as Medical Device) that is customer-facing and provides remote access through a web application for viewing/reviewing images as well as the ability to remotely provide real-time guidance to the near-patient licensed technologist (local users) operating the medical imaging devices in the context of training, procedure assessment, for MRI, CT, and PETMedical image management and processing system CT scanner. Remote users are licensed technologists and are able to access an imaging medical device from a computer that meets the minimum required specifications anywhere, using a secure software connection that streams video and provides keyboard and mouse access. This allows remote users to assist local users, with both remote and local users' qualifications and responsibilities being subject to local regulations where the imaging occurs. This access must be granted by the local user using the system, and it can also be revoked at any time by the local user, thus allowing him/her to maintain complete control of the session at all times. Also, each remote session is controlled via a secure credential that is managed by the local user. Connections to a medical device are limited to one remote session at a time to maintain strict control over who is remotely interacting with the system. Images reviewed remotely are not for diagnostic use. nCommand Lite is an IT hardware and software-based installation solution that supports multisession, allowing remote technologists to view multiple medical imaging devices as needed. However, access is restricted to one medical imaging device at any given time, as only one keyboard and one mouse are provided. Scanners that are compatible with nCommand Lite system comply with a common protocol, allowing for scanning parameter management and remote scanning.