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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

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.

The IBM iConnect Access application provides internet access to multi-modality softcopy medical images, reports, and other patient-related information to conduct diagnostic review, planning and reporting through the interactive display and manipulation of medical data. IBM iConnect Access provides healthcare professional tools to aid in interpreting medical images including: - · Displaying DICOM compliant medical images and non-DICOM content using XDS - · Reformatting images, including creation of MPRs, MIPS, MinIPs, color/monochrome 3D volume rendered images · Manipulating displayed images via control of slice interval, obliquity, perspective, rotation, window/ level, crop, zoom, color/monochrome transformation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path. - · Creating individually captured DICOM images that can be displayed and stored in a PACS • Measuring coronary calcium, which is intended for non-invasive identification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms. · 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. The IBM iConnect Access application 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 IBM iConnect Access application on mobile devices such as iPhones and iPads is not intended for diagnostic use.

IBM iConnect Access provides healthcare professionals with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP networks. With no download or application-specific installation required on the user's computer, healthcare professionals can use IBM iConnect Access with a standard internet browser to view exams and patient information including but not limited to the following content: Diagnostic Reports. Kev Images, Presentation Series, Modality Imaging, Scope/ Surgery Videos, Visible Light, and File Attachments. IBM iConnect Access 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, line/ angle/ ROI measurements, and MPR. The software displays patient studies and other patient data but does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user. When configured by an Administrator, patients can view their radiological information via portals that launch IBM iConnect Access and provide the ability to view clinical results, modality imaging, key images, scope/surgery videos, and associated clinical documentation. The role for patient access is limited to zooming the image, panning the image, and scrolling through a series of images. The IBM iConnect Access 3D advanced imaging solution supports MIP (maximum intensity project), MPR (multiplanar reconstruction), 3D volume rendering, and cardiac calcium scoring. Reading physicians, referring physicians, and other appropriate healthcare personnel and can employ advanced image processing and display from local or remote locations. IBM iConnect Access provides advanced image segmentation and editing tools for the purpose of creating digital 3D anatomical models. These models can be exported as STL files for the purpose of fabricating physical replicas, such as 3D printing. Physical/3D printed models generated from the digital output files are not for diagnostic use. IBM iConnect Access can be used to query and retrieve content from the IBM iConnect Enterprise Archive. IBM iConnect Enterprise Archive is a software system that supports storage and communications of medical images and data. Qualified system administrators monitor and maintain the software in their healthcare enterprise environment. IBM iConnect Suite is an offering that combines the image storage capability of IBM iConnect Enterprise Archive with the diagnostic viewer capability of IBM iConnect Access.

Merge PACS™ is a Picture Archiving and Communication System (PACS) for multi-modality (CT, MR, PT, US, MG, BTO, CR, DR/DX, NM, XA, RF, secondary capture (SC), and other DICOM-compliant modalities) image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data. Intended clinical users include radiologists, orthopedic and other surgeons, referring physicians, and other qualified medical professionals.

Merge PACS, a software medical device, is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians' worklists and retrieving and managing studies for reading, reporting, communication, and storage. Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) via DICOM protocol, for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.) via HL7. Merge PACS can be accessed from within the hospital or enterprise, or from remote locations via web-based access. Images viewed on mobile devices should not be used for diagnostic purposes. The focus of this premarket notification is on the addition of the Region Analysis Area and Region Analysis Volume tools, which allows for additional clinical analysis of images, including volumetric Standard Uptake Value (SUV) calculation. There has been a minor change in the indications for use statement from the previous Merge PACS device, with the removal of the optional Reach component which is no longer offered. Additional non-significant changes since the previous submission will be discussed.

Merge Cardio software product is an integrated multi-modality image and information system designed to perform the necessary functions required for import, export, review, analysis, quantification, reporting, and database management of digital cardiovascular images, documents, and data related to cardiology. Merge Cardio offers support for third-party applications in order to enable the use of commercially available tools and specified applications for analysis, quantification, and reporting. Merge Cardio software runs on standard information technology hardware and software, using standard information technology operating systems and user interfaces. Communication and data exchange are done using standard protocols. The modular design allows configurability to tailor the image import and communications solution to the needs of the user. The number of modalities and reporting and/or viewing sites can be configured per system.

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 information technology operating systems and user interfaces. Communication and data exchange are done using standard protocols.

The IBM iConnect Access application provides internet access to multi-modality softcopy medical images, reports, and other patient-related information to conduct diagnostic review, planning and reporting through the interactive display and manipulation of medical data. IBM iConnect Access provides healthcare professional tools to aid in interpreting medical images including: o Displaying DICOM compliant medical images and non-DICOM content using XDS o Reformatting images. including creation of MPRs. MIPS. MinIPs. color/monochrome 3D volume rendered images o Manipulating displayed images via control of slice interval, obliquity, perspective, rotation, window/ level, crop, zoom, color/monochrome transformation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path. o Creating individually captured DICOM images that can be displayed and stored in a PACS o Measuring coronary calcium, which is intended for non-invasive identification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms. The IBM iConnect Access application 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 IBM iConnect Access application on mobile devices such as iPhones and iPads is not intended for diagnostic use.

IBM iConnect Access provides healthcare professionals with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP networks. With no application-specific installation required on the user's computer, healthcare professionals can use IBM iConnect Access with a standard internet browser to view studies and patient information including but not limited to the following content: Diagnostic Reports, Key Images, Presentation Series, Modality Imaging, Scope/ Surgery Videos, Visible Light, and File Attachments. IBM iConnect Access 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, line/ angle/ ROI measurements, and MPR. The software displays patient studies and other patient data but does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user. The IBM iConnect Access 3D advanced imaging solution supports MIP (maximum intensity project). MPR (multiplanar reconstruction). 3D volume rendering, and cardiac calcium scoring. Reading physicians, referring physicians, and other appropriate healthcare personnel can employ advanced image processing and display from local or remote locations. IBM iConnect Access can be used to query retrieve content from the IBM iConnect Enterprise Archive. IBM iConnect Enterprise Archive is a software system that supports storage and communications of medical images and data. Qualified system administrators monitor and maintain the software in their healthcare enterprise environment. IBM iConnect Access along with IBM iConnect Enterprise Archive comprise a cloud based solution marketed as iConnect Cloud Archive. The IBM iConnect Access 3D advanced imaging solution option is not available on iConnect Cloud Archive.

Merge PACS™ is a Picture Archiving and Communication System (PACS) for multi-modality (CT, MR, PT, US, MG, BTO, CR, DR/DX, NM, XA, RF, secondary capture (SC), and other DICOM-compliant modalities) image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data. Intended clinical users include radiologists, orthopedic and other surgeons, referring physicians, technologists, and other qualified medical professionals. Data can be received directly from acquisition modalities, CAD systems, and other image processing systems, or indirectly via importing. Data that is not DICOM-compliant, such as photos, can be converted to DICOM format by Merge PACS. Merge PACS provides image manipulation tools to enable users to view and compare images such as: linkinq, MPR, MIP, 3D image fusion/registration of CT, MR, and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae). The Real Time Worklist (RTWL) displays the real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, configurable components. The Patient Dashboard provides a composite view of patient data, both imaging and non-imaging. The optional Reach component provides clinicians with secure, proactive communication and access to clinical reports and images. Multi-tier patient identity matching provides a comprehensive view even when dealing with multiple disparate patient identities. Order and report information generated by the HIS/RIS and report creation systems are received and displayed via the transmission of HL7 messaging. Lossless (reversible) and lossy (irreversible) image compression are supported for viewing, storage and communication. Merge PACS displays full fidelity DICOM images for use in the diagnostic interpretation of mammography using MG or BTO images. Thick slab MIP presentation can be applied to BTO images. Lossy compressed images and digitized screen film images must not be used for primary diagnosis of mammography studies, and only display monitors that have regulatory clearance for mammography interpretation should be used for the interpretation of mammography studies.

Merge PACS™, a software medical device, is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians' worklists and retrieving and managing studies for reading, reporting, communication, and storage. Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.). Merge PACS can be accessed from within the hospital or enterprise, or from remote locations via web-based access. Images viewed on mobile devices must not be used for diagnostic review. The focus of this premarket notification is on the addition of the ability to "fuse" images for viewing (image fusion) and on the ability to measure Standardized Uptake Values (SUV) on PET (Positron Emission Tomography) images.

Merge Hemo displays, measures, and records physiological data from a patient undergoing a cardiac catheterization procedure. The Hemo System can visualize and capture vital sign values including ECG, impedance respiration, SpO2 and Pleth waveforms, invasive blood pressure, non-invasive blood pressure (NIBP). Thermodilution cardiac output and Fractional Flow Reserve (FFR). The system can display and capture diagnostic quality 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 EtCO2 waveform. The hemodynamic portion of the system is comprised of the Patient Data Module (PDM) and the Merge Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters are acquired and calculated in the PDM. This data is then transmitted to the Merge Hemo Monitor PC via the serial interface. All data can then be displayed on the Merge Hemo Monitor PC. The Merge Hemo system is not intended to produce alarms for out-of-range conditions. Patient allergies and current medication information can be entered by the system. If desired and using a third party database the Hemo system can display drug to allergy interaction information. The system is intended for use in hospital catheterization laboratories and in pre-and post-procedure care areas in the hospital under the close supervision of qualified medical personnel.

Merge Hemo is a hemodynamic recording and display system designed to measure, record, and display vitals signs data for patients undergoing cardiac catheterization procedures. The addition of a Merge Hemo software feature that provides the ability to calculate and display Fractional Flow Reserve (FFR) values is described. No hardware changes are required in order to enable or perform this functionality. FFR provides a quantitative assessment of the functional severity of a coronary artery stenosis identified during coronary angiography and cardiac catheterization. FFR measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery. The Merge Hemo software user interface displays the pressure waveforms from the third party FFR pressure transducers that are placed distal and proximal to the lesion. When the FFR feature is enabled, the system shows the section of each of the waveforms that is used to calculate the mean pressure. The results of the pressure waveform recording is expressed as a fraction of the normal blood flow in the coronary artery compared to the maximum achievable blood flow in the same artery. An FFR measurement of 1.0 indicates an artery with normal blood flow. FFR measurements less than 0.80 indicate that ischemia could be caused by blood flow blockage. The Merge Hemo software initially selects segments of the waveforms to use for FFR calculations but the user can easily change where the values are taken by using the touchscreen interface to move the segment markers along the waveforms. The FFR value recalculates accordingly.