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McKesson Cardiology™ is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images and information from other data sources. McKesson Cardiology™ is intended for use in the Cardiology, Radiology or other departments throughout the healthcare facility and distributed locations and may be part of a larger PACS configuration. McKesson Cardiology™ offers support for third-party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting. McKesson Cardiology™ is intended to assist trained professionals in the viewing and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. The version of McKesson Cardiology, subject of this 510(k), allows for the provision of additional information from expanded data sources to assist trained healthcare professionals throughout the healthcare facility and distributed locations in diagnosing and treating cardiac and vascular diseases.

McKesson Cardiology™ is an image processing system. The device consists of the following components and accessories: software application; database server; application server; image and document storage server and media; long-term archive and disaster recovery media; and client application workstation. The version of McKesson Cardiology, subject of this 510(k) includes enhancements and new features including those for supporting dictation and streamlining user workflow for documenting, charting and trending procedural related data for Cath and other reporting; Statistical data collection of non-invasive features use for adoption considerations; Security; DICOM display view; Storage and archival enhancements; Support for stress modalities XML data import; EP modalities data import and reporting; and, importing lab results and exporting procedure medications using standard HL7.

McKesson Cardiology ECG Mobile is a software application used for accessing and displaying ECG data and related patient information previously stored, analyzed or retrieved by the Horizon Cardiology ECG Management device. The McKesson Cardiology ECG Mobile software application is intended to be used from a mobile device to perform the following: - View ECG test results, such as waveforms, synopsis measurements and diagnosis statements, as well as other relevant current or historical patient information originally stored, analyzed or retrieved by the Horizon Cardiology ECG Management device. - View the ECG lead traces using different display settings. - . Compare the results of current ECG tests with any previous ECG test results stored on the Horizon Cardiology ECG Management device. - . Perform ECG-related measurements and edit synopsis measurement values stored on the Horizon Cardiology ECG Management device. - Enter new diagnosis statements and/or modify diagnosis records stored on the Horizon . Cardioloģy ECG Management device. - . Confirm ECG procedures and results. - . Communicate information with the Horizon Cardiology ECG Management device such as login credentials and user settings. The McKesson Cardiology ECG Mobile application is intended to be used under the direct supervision of a licensed healthcare practitioner and by trained operators. The McKesson Cardiology ECG Mobile application is not intended for real-time monitoring.

McKesson Cardiology ECG Mobile provides secure access to ECG records and related information contained on the Horizon Cardiology ECG Management device. The McKesson Cardiology ECG Mobile software functions as an accessory to the Horizon Cardiology ECG Management device, and requires a WiFi or cellular connection to a pre-installed and properly configured Horizon Cardiology ECG Management device. Through providing remote access to the ECG data stored on the McKesson Cardiology ECG Management device, the user is able to review current and previous ECG tests results, perform measurements on the ECG waveforms, and edit and confirm the ECG test results. McKesson Cardiology ECG Mobile does not store ECG or patient related information on the mobile device, does not directly communicate with cardiographs or other waveform acquisition devices, and does not use any automatic electronic data processing and pattern recognition methods to derive measurements (e.g. intervals and amplitudes) or provide diagnostic statements from the ECG data. The device does not allow modification of the original ECG traces (waveforms) stored on the Horizon Cardiology ECG Management device. The McKesson Cardiology ECG Mobile application is not intended to replace the functionalities provided by the Horizon Cardiology ECG Management desktop client but to extend those to make selected functionalities described above available via mobile devices. The McKesson Cardiology ECG Mobile functions as a non-real time system and is not intended for real time monitoring. McKesson Cardiology ECG Mobile can be used both inside of medical facilities except in areas where cellular phone or wireless device use is prohibited. McKesson Cardiology ECG Mobile is intended to operate on Apple®iPad running iOS mobile operating system from Apple Inc.

McKesson Cardiology™ Hemo is intended for complete physiological/hemodynamic monitoring. clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology™ Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, storing, storing, carrying, 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. McKesson Cardiology™ Hemo is intended for use in the areas of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other areas where 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 for unattended patient monitoring or in situations where arrhythmia detection is required.

The McKesson Cardiology™ Hemo 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 areas of in the areas of: cardiology, cardiac catheterization, electrophysiology, invasive radiology, and other areas where patient/procedural data management is needed. McKesson Cardiology™ Hemo also acquires patient information from other hospital information systems and makes hemodynamic information available to them. It facilitates seamless interfacing with hospital information systems and cardiac image management, archiving and reporting systems. McKesson Cardiology™ Hemo incorporates the FDA cleared the ARGUS PB vital signs monitoring device (K012226), manufactured by Schiller AG, which provides patient monitoring via: - ECG leads . - Invasive Blood Pressure (non-McKesson transducers) . - SpO2 sensor . - Non-invasive blood pressure (NIBP) cuff . - . Temperature probe - . Thermal Dilution Cardiac output temperature probe (connected to a non-McKesson Cardiac Output catheter) - . CO2 (connected to non-McKesson cannulas or intubation tubes) Disposables and accessories (transducers, cannulas and intubation devices) are not part of the McKesson Cardiology™ Hemo system, but are supplied by the end user facility as required. McKesson Cardiology™ Hemo 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 Unit that incorporates the 'Clinical System' and the 'Front-End' unit (which . incorporates the Schiller Argus PB device - K012226). The clinical unit is responsible for acquiring, analyzing and displaying patient vitals and other pertinent clinical data. The data is displayed on monitors.

Horizon Cardiology™ ECG Management is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices. Horizon Cardiology™ ECG Management allows analysis of resting ECGs and provides preliminary data for editing and confirmation by an over-reading physician. Horizon Cardiology ECG Management can also provide a serial comparison of resting ECG data to facilitate review of a patient's current ECG with previous ECGs of the same patient. Horizon Cardiology™ ECG Management is intended to be used under the direct supervision of a licensed healthcare practitioner and by trained operators in a hospital or facility providing patient care. Horizon Cardiology ECG Management is not intended for real-time monitoring.

Horizon Cardiology™ ECG Management is a standard ECG management system for importing ECG waveform data, reviewing, performing measurements, diagnosis and comparison of ECG procedures and storing them for future review and management. Horizon Cardiology™ ECG Management functions as a non-real time system. It receives ECG procedure files after the cessation of the ECG procedure, which can originate from any one of a variety of manufacturer's cardiographs, Stress ECG machines, Holter recording devices or Holter analysis and review stations. Horizon Cardiology™ ECG Management acquires the ECG waveforms through a network connection or via a diskette, and normalizes them to a common format. If the ECG cart has made an ECG procedure analysis, Horizon Cardiology™ ECG Management presents it and utilizes the Glasgow University Interpretive Algorithm to perform its own measurements, diagnosis and serial comparison without changing the raw waveform data. Horizon Cardiology™ ECG Management acquires the Stress and Holter ECG files in PDF format through a network connection, modem or via a portable media (diskette, SD card, etc.) or wireless device and stores them in their original format without changing the file. Horizon Cardiology™ ECG Management uses an intuitive interface, which provides tools to edit measurements and procedure diagnoses and enables the physician to seamlessly review numerous ECG procedures. Horizon Cardiology™ ECG Management complies with HL7 standards for export to the Hospital Information System (HIS) to provide billing information. Horizon Cardiology7™ ECG Management supports final ECG report distribution by printing, faxing, e-mailing and automatic export to other systems. The Horizon Cardiology™ ECG Management database complies with the requirements of HIPAA through robust password security, record access security and file allocation in a secure and managed server. Horizon Cardiology™ ECG Management allows access to ECG records from web-enabled PC's throughout a network and enables authorized clinical users to access the system from remote locations.

Horizon Cardiology™ is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images. Horizon Cardiology™ is intended for use in the Cardiology, Radiology or other departments throughout the healthcare facility and may be part of a larger PACS configuration. Horizon Cardiology™ offers support for third party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting.

Horizon Cardiology™ is an image processing system. The device consists of the following components and accessories: software application; database server; web server; application server; image and document storage server and media; long term archive and disaster recovery media; and client application workstation.