Search Results

Merge Universal Viewer (MUV) is intended to provide internet access to multi-modality softcopy medical images, medical data, reports, and other patient-related information to conduct diagnostic review, processing, analyzing, reporting and sharing of DICOM-compliant medical images and relevant digital data. MUV provides functionality that allows for creating and outputting digital files suitable for the fabrication of physical replicas, such as 3D printing, using DICOM files as inputs. Physical/3D printed models generated from the digital output files are not for diagnostic use. MUV is intended to be used by trained healthcare professionals. MUV can be configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA. Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Use of MUV on mobile devices such as iPhones and iPads is not intended for diagnostic use.

Merge Universal Viewer (formerly known as IBM iConnect Access) is a software application that is intended to provide internet access to multi-modality softcopy medical images, medical data, reports, and other patient-related information to conduct diagnostic review, processing, analyzing, reporting and sharing of DICOM-compliant medical images and relevant digital data. Merge Universal Viewer provides healthcare professionals with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP networks. Merge Universal Viewer was designed with an easy and convenient workflow providing image viewing and manipulation capabilities including but not limited to zoom, pan, window/level, scroll, CINE, link series, and MPR. Additionally, the existing Merge Universal Viewer offers measurement and analysis tools such as line measurement, cross reference lines, rectangle, ellipse, perfect circle, freehand ROI, angle, Cobb angle, calibration, pixel value, plumb lines and cardiac calcium scoring. A high-level overview of the modifications to the subject device being introduced as part of this 510(k) are as follows: - Ability to display Mammography CAD SR - Addition of the Volumetric SUV (Standard Uptake Value) to the measurement tools - Addition of a DICOM Structured Report (SR) ingestion panel: The "Findings Panel": - Display of lung nodule detection and characteristics - Generalized lesion tracking (for CT and MR studies) - Addition of cardiology measurement tools (for cardiac ultrasound studies) - Miscellaneous updates such as: - Cybersecurity improvements to ensure full compliance with FDA's Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance issued September 27, 2023. - The ability to display mammography images in full resolution using a keyboard shortcut - Bug fixes - Labeling update, i.e., revised Indications for Use statement to reflect the new branding as well as to align with the current industry standards to consolidate the information

MR Contour DL generates a Radiotherapy Structure Set (RTSS) DICOM with segmented organs at risk which can be used by trained medical professionals. It is intended to aid in radiation therapy planning by generating initial contours to accelerate workflow for radiation therapy planning. It is the responsibility of the user to verify the processed output contours and user-defined labels for each organ at risk and correct the contours/labels as needed. MR Contour DL is intended to be used with images acquired on MR scanners, in adult patients.

MR Contour DL is a post processing application intended to assist a clinician by generating contours of organ at risk (OAR) from MR images in the form of a DICOM Radiotherapy Structure Set (RTSS) series. MR Contour DL is designed to automatically contour the organs in the head/neck, and in the pelvis for Radiation Therapy (RT) planning of adult cases. The output of the MR Contour DL is intended to be used by radiotherapy (RT) practitioners after review and editing, if necessary, and confirming the accuracy of the contours for use in radiation therapy planning. MR Contour DL uses customizable input parameters that define RTSS description, RTSS labeling, organ naming and coloring. MR Contour DL does not have a user interface of its own and can be integrated with other software and hardware platforms. MR Contour DL has the capability to transfer the input and output series to the customer desired DICOM destination(s) for review. MR Contour DL uses deep learning segmentation algorithms that have been designed and trained specifically for the task of generating organ at risk contours from MR images. MR Contour DL is designed to contour 37 different organs or structures using the deep learning algorithms in the application processing workflow. The input of the application is MR DICOM images in adult patients acquired from compatible MR scanners. In the user-configured profile, the user has the flexibility to choose both the covered anatomy of input scan and the specific organs for segmentation. The proposed device has been tested on GE HealthCare MR data.

Change Healthcare Stratus Imaging PACS is a software-based medical image management and processing system intended to process and display medical images for the purposes of diagnostic viewing and interpretation by qualified and trained healthcare professionals, including, but not restricted to, radiologists and non-radiology physicians. The Diagnostic Viewer of Change Healthcare Stratus Imaging PACS provides medical image postprocessing functions such as image manipulation and enhancement that are intended for use in the clinical image review and analysis of medical images acquired through DICOM-compliant imaging devices or IT interfaces. Change Healthcare Stratus Imaging PACS can be used as a full-featured medical image management and processing system or as an independent viewer in clinical settings. Only uncompressed or non-lossy compressed DICOM images can be used for primary image diagnosis and interpretation for mammography using monitors intended for mammography display and cleared by the requlatory authority in your region or jurisdiction. Change Healthcare Stratus Imaging PACS is not intended for diagnostic use on mobile devices.

Change Healthcare Stratus Imaging PACS is a software-based medical image management and processing system designed to perform the necessary functions required for diagnosis and interpretation of medical information. It is intended to be used by qualified and trained radiology physicians for the purpose of assisting in diagnosis and interpretation of medical images. Change Healthcare Stratus Imaging PACS provides users with a zero-footprint, browser-based diagnostic viewer capable of directly displaying diagnostic quality DICOM standard images, reports and discrete data information acquired by various data sources. The diagnostic viewer provides users with tools and features, including measurement, annotations, comparison, and digital processing of medical images, such as image manipulation, enhancement, and 3D/4D visualization. Change Healthcare Stratus Imaging PACS functionality, such as storage, import, sharing, retrieval, and display, that supports the day-to-day operations of qualified and trained healthcare professionals, such as technologists and PACS administrators. Change Healthcare Stratus Imaging PACS uses a cloud-based architecture offering zero-footprint deployment in hospitals, clinics imaging centers and other healthes. Authorized users from both clinical facilities and remote locations can directly access Change Healthcare Stratus Imaging PACS. Change Healthcare Stratus Imaging PACS operates on approved web browsers running on commercially available hardware that meets approved specifications. Change Healthcare Stratus Imaging PACS is designed to integrate with third party, off-the-shelf software through Application Programming Interfaces (APIs) and supported standards (for example, HL7, DICOM) to allow connectivity with systems used in the clinical environment such as reporting tools, EMRs, and advanced visualization tools.

ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic ultrasound. ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes. ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system. ViewPoint 6 is not intended to operate medical devices in surgery related procedures.

ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data. ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It is designed with intuitive graphical user interfaces (GUIs) and is based on Microsoft Windows® with defined hardware requirements. Viewpoint 6 provides exam type specific reporting forms for various medical care areas. Forms are composed of different sections with data entry fields. The documentation can include measurements, exam findings, images and graphs. All data is saved in the ViewPoint 6 database and can be compiled to a professional report. Images and image sequences can be reviewed in the ViewPoint 6 display area based on user preference. ViewPoint 6 supports both a single workstation and a client/browser - server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read-only functionality. ViewPoint 6 software is a server-based application with client-server architecture, accessed via client computers or mobile devices as well as browser-based systems. Viewpoint 6 is installed on client provided servers within a hospital network. The software comes with features to view, annotate, measure, calculate, save and retrieve clinical data (including images via DICOM format) to support patient documentation and record keeping related to ultrasound image scans. Additionally, the software is available for patient administrative tasks such as appointment scheduling and exam billing. This product does not control or alter any of the medical devices providing data across the hospital network.

Merge Hemo displays, measures, and records physiological data from patients undergoing invasive catheter-based diagnostic and interventional procedures. The Hemo System can visualize and capture vital sign values including ECG, impedance respiration, SpO2 and Pleth waveforms, invasive blood pressure, temperature, non-invasive blood pressure (NIBP), Thermodilution cardiac output and Fractional Flow Reserve (FFR). The system can display and capture 12 Lead resting ECG to visualize arrhythmias, and ST-segment changes. Some Hemo systems have an option to measure and display Side-stream End Tidal Carbon Dioxide (EtCO2) along with apnea and respiration rates calculated from the EtCQ2 waveforms. The system can also perform specified calculations from captured or manually entered values. The hemodynamic portion of the system is comprised of the Patient Data Module (PDM) and the Merge Hemo Monitor PC. All vital parameters are acquired in the PDM. This data is then transmitted to the Merge Hemo Monitor PC. All data can then be displayed on the Merge Hemo Monitor PC. User-adjustable visual alarms available in the system alert the operator to anomalous occurrences and facilitate timely responses. Patient allergies and current medication information can be entered by the user and displayed by the system. If desired and using a third-party database, the Hemo system can display drug or drug-to-allergy interaction information. The Merge Hemodynamic system is intended for use in invasive catheter-based diagnostic and interventional procedure laboratories and in pre- and post-procedure care areas in professional health care facilities. The Merge Hemo system is intended for use under the close supervision of qualified medical personnel. The system is not intended patient monitoring or in situations where arrhythmia detection is required. This system is used in the diagnosis and treatment of cardiovascular, peripheral vascular, and cardiac diseases. The system is designed for patients of Infant to Adult ages. The system is to be used in invasive procedural laboratories under the direct supervision of physicians, nurses, and technicians.

The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology. The device consists of off-the-shelf computer hardware such as personal computers and servers, a Patient Data Module (PDM) that acquires patient vitals received from accessories such as ECG electrodes, invasive catheters/pressure transducers, and temperature probes, and transmits them to the Merge Hemo Monitor. The Merge Hemo system includes a Record Station with options to add a Procedure Room Hemo Monitor or a Remote Operators Terminal (ROT). The Record Station Workstation for Merge Hemo, Model RCSV2 is made up of medical grade Hemo Client and Hemo Monitor All-in-One computers with built-in display monitors. The new PDM component, the ARGUS PB-3000 manufactured by Schiller AG, acquires the following patient vitals: ECG, Invasive Blood Pressure, SpO2, Non-Invasive Blood Pressure, Temperature, Cardiac Output, and CO2, digitizes the signals, and transmits them to the Hemo Monitor in the Record Station. The Client side of the Record Station is responsible for the documentation, display, storage, and distribution of the data acquired during the procedure.

True Enhance DL is a deep learning-based image processing method trained to estimate monochromatic, 50 keV GSI images. The algorithm is intended to improve the contrast of 120 kVp, single energy images of the body. This device is intended to provide non-quantitative, adjunct information and should not be interpreted without the original 120 kVp image. True Enhance DL may be used for patients of all ages.

True Enhance DL is a deep learning-based image processing method for contrast enhanced images of the body obtained using the Revolution Ascend Family (K213938), which consists of multiple commercial configurations: Revolution Ascend Elite, Revolution Ascend Plus, and Revolution Ascend Select. True Enhance DL is intended to post-process single energy, 120 kVp images to output nonquantitative, adjunctive information with better contrast than single energy input data. True Enhance DL brings four deep leaning models that the user can choose depending on different contrast enhancement phases. These four models are CT Angiography, Arterial, Portal/Venous, and Delayed True Enhance DL. True Enhance DL is not intended to replace hardware based Monochromatic Imaging by Gemstone Spectral Imaging (GSI) technology or replicate GSI dual energy acquisitions. The device was trained to estimate monochromatic, 50 keV GSI images, and only enhances images from 120 kVp acquisitions on non-GSI Revolution Ascend systems.

The SIGNA™ Champion is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMI, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by SIGNA™ Champion reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

SIGNA™ Champion is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time. The system uses a combination of time-varying magnet fields (Gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system features a 1.5T superconducting magnet with 70cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

Digital Expert Access with Remote Scanning is intended as a remote collaboration tool to view and review MR images, to remotely control MR Imaging Devices and to initiate MRI scans remotely. Digital Expert Access with Remote Scanning is a remote scan assistance solution which allows remote control of an MR Imaging Device including the ability to initiate a scan remotely. This access provides real time communication mechanisms between the remote and onsite users to facilitate the acquisition occurring on the device. Access must be granted by the onsite user operating the system. Images reviewed remotely are not for diagnostic use.

Digital Expert Access is a variation of the Customer Remote Console cleared under K150193. It is a remote scan assistance solution designed to address the skill variability in technologists and their need for ondemand support by allowing them to interact directly with a remote expert connected to the hospital network. By enabling the collaboration between an Onsite Technologist and Remote Expert, Digital Expert Access helps the onsite technologist to seek guidance and real time support on scanning related queries including but not limited to training, procedure assessment, and scanning parameter management. Digital Expert Access with Remote Scanning introduces a feature that enables the Remote Expert to initiate a scan and make changes in real time during the scanning session. This remote scan feature is only available when Digital Expert Access is connected to a compatible GE HealthCare MRI system. Digital Expert Access with Remote Scanning enables the following capabilities for the Onsite Technologist and the Remote Expert: - 1. Collaborative session between an Onsite Technologist and Remote Expert - 2. Real-time scanner screen share and live annotation - ന് Remote console access and control - 4. Remote Scan Initiation Digital Expert Access with Remote Scanning is not intended for diagnostic use or patient safety-related management. This solution is not intended to be used by individuals who are not properly trained in the operation of GE HealthCare Medical Imaging systems. Digital Expert Access with Remote Scanning does not directly interface with any patients and requires the Onsite Technologist to be continuously present throughout the scanning procedure. Digital Expert Access with Remote Scanning does not acquire any MRI images, nor does it do any post image processing. All image acquisition and image processing is conducted by the GE HealthCare MRI system.

Change Healthcare Cardiology Hemodynamics™ is intended for complete physiological/hemodynamic monitoring. clinical data acquisition, medical image and data processing, and analytical assessment. Change Healthcare Cardiology Hemodynamics™ is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data. Data may also be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices. Change Healthcare Cardiology Hemodynamics™ is intended for use in the areas of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other patient/procedural data management is needed. User-adjustable alarms (both visual and audible) available in the system alert the operator to anomalous occurrences and facilitate timely responses. Use of the system is not intended patient monitoring or in situations where arrhythmia detection is required.

The Change Healthcare Cardiology Hemodynamics™ device is a hemodynamic monitoring system for monitoring vital signs, performing measurements and calculations, documenting procedure and patient data and interfacing to other systems and devices during and after procedures in the area of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other areas where patient/procedural data management is needed. Change Healthcare Cardiology Hemodynamics™ also acquires patient information from other hospital information systems and makes hemodynamic information available to them. It facilitates interfacing with hospital information systems and cardiac image management, archiving and reporting systems. Change Healthcare Cardiology Hemodynamics™ incorporates the Argus PB-3000 vital signs monitoring device (K221056), manufactured by Schiller AG, which provides patient monitoring via: - ECG leads - Invasive Blood Pressure (connected to non-Change Healthcare transducers) - SpO2 finger clip - Non-invasive blood pressure (NIBP) cuff - Temperature probe - Thermal Dilution Cardiac output temperature probe (connected to non-Change Healthcare Cardiac Output catheter) - CO2 (connected to non-Change Healthcare cannulas or intubation tubes) Argus PB-3000 monitoring device is provided with compatible accessories (cables, sensors, cuffs, probes, etc). Appendix L of the Change Healthcare Cardiology Hemodynamics User Guide includes a List of qualified PB-3000 accessories. Change Healthcare Cardiology Hemodynamics™ is composed of: - A control and documentation unit (Information System) that is used for administration, performing measurements, recording full disclosure, taking samples and entering procedure notes and overall data input and management of the patient and procedure data. - A Clinical System that incorporates the RT Monitor and the Front-end (which incorporates the Schiller Argus PB-3000 device). The clinical system is responsible for acquiring, analyzing, and displaying patient vitals and other pertinent clinical data. The data is displayed on monitors. Change Healthcare Cardiology Hemodynamics™ uses an interface that displays patient data, procedure data, waveforms, and numeric values. The performing physician views the monitor, and conveys instructions and procedure notes to the technician, who operates the application using a touch screen, keyboard and mouse, for maximum convenience. The control and documentation unit (Information System) can function independently from the Clinical unit and therefore can be setup without the clinical unit for instances where only patient/procedure documentation is required. In addition, the Change Healthcare Cardiology Hemodynamics™ system can receive and/or export data from 3rd party devices and systems. One such utilization is the ability to import monitored parameter data from 3rd party bedside monitors for documentation purposes as part of the patient's log (part of the Holding Area Charting configuration). This import is performed via the utilization of FDA cleared Capsule's SmartLinx software (K200856) that is intended for clinical information management through networks with independent devices. Physicians can instruct the technician to configure the appearance, content and layout of the display on the monitors that display the patient's vitals and other pertinent clinical data (real-time monitors) and to perform real-time functions and measurements using the tools that exist in the control and documentation unit. This pane can be shown or hidden at any time by clicking Procedure Control in the display control bar. Each pane in the real-time controls area can be expanded to show more content and contracted to save space when that content is not needed. Changes should be made only upon request or instruction of the physician. The clinical system resides on a dedicated computer to ensure that it is not vulnerable to failure of the network or the backend computer on which the application resides. In case of application failure, the system knows how to restart itself and restore a stable OS environment on the computer. Watchdogs are in place to prevent failure.

Sonic DL is a Deep Learning based image reconstruction technique that is available for use on GE Healthcare 1.5T and 3.0T MR systems. Sonic DL reconstructs MR images from highly under-sampled data, and thereby enables highly accelerated acquisitions. Sonic DL is intended for cardiac imaging, and for patients of all ages.

Sonic DL is a new software feature intended for use with GE Healthcare MR systems. It consists of a deep learning based reconstruction algorithm that is applied to data from MR cardiac cine exams obtained using a highly accelerated acquisition technique. Sonic DL is an optional feature that is integrated into the MR system software and activated through a purchasable software option key.