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510(k) Data Aggregation

    K Number
    K142850
    Device Name
    McKesson Radiology Mammography Plus
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Date Cleared
    2015-01-06

    (98 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MCKESSON MEDICAL IMAGING COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    McKesson Radiology Mammography Plus™ ("Mammography Plus"), is an accessory to McKesson Radiology Station™, a component of McKesson Radiology™. McKesson Radiology is medical image and information management software that is intended to receive, transmit, store, archive, manage, display, print and process digital medical images, digital medical video and associated patient and medical information. McKesson Radiology™ includes a suite of standalone, web-enabled software components, and is intended for installation and use with off-the-shelf hardware that meets or exceeds minimum specifications. McKesson Radiology Station™ is the primary software component used for processing and presentation of medical images on display devices with network access to McKesson Radiology. McKesson Radiology Station is intended to process and display lossless and non-lossed medical images provided from DICOM conformant modalities such as X-Ray Radiography (including digital mammography), X-Ray Computed Tomography, Magnetic Resonance Imaging. Ultrasound, and Nuclear Medical images obtained from other DICOM-compliant modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. McKesson Radiology is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists. non-radiology specialists, physicians and technologists.
    Device Description
    Mammography Plus, an accessory to the McKesson Radiology Station, the radiology viewing component of McKesson Radiology, consists of image display and manipulation tools that help radiologists zoom in onto an image, interpret Computer Aided Detection (CAD) findings, navigate through and visualize digital mammography and Digital Breast Tomosynthesis (DBT) images, compare historically similar images, and configure their reading environment. Mammography Plus uses the underlying capabilities of McKesson Radiology's diagnostic viewer, McKesson Radiology Station, to integrate specialized functionality into the diagnostic reading workflows. The McKesson Radiology Station viewer interfaces with the McKesson Radiology Platform to access patient and study information.
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    K Number
    K140909
    Device Name
    MCKESSON RADIOLOGY
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Date Cleared
    2014-07-02

    (84 days)

    Product Code
    LLZ, DEV
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MCKESSON MEDICAL IMAGING COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    McKesson Radiology™ is medical image and information management software that is intended to receive, transmit, store, archive, retrieve, manage, display, print and process digital medical images, digital medical video and associated patient and medical information. McKesson Radiology includes a suite of standalone, web-enabled software components, and is intended for installation and use with off-the-shelf hardware that meets or exceeds minimum specifications. McKesson Radiology Station™ is the primary software component used for processing and presentation of medical images on display devices with network access to McKesson Radiology. McKesson Radiology Station is intended to process and display lossless and non-lossless compressed medical images provided from DICOM conformant modalities such as X-Ray Radiography (including digital mammography), X-Ray Computed Tomography, Magnetic Resonance Imaging, Ultrasound, and Nuclear Medicine, as well as medical images obtained from other DICOM-compliant modalities. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. McKesson Radiology is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists.
    Device Description
    McKesson Radiology, a Picture Archiving and Communication System (PACS), consists of configurable software-only applications that receive, transmit. store, archive, retrieve, manage, display, print and process digital medical images, digital medical video and associated patient and medical information to aid in the day-to-day operations and workflow of clinicians and healthcare practitioners. It includes the primary diagnostic viewer McKesson Radiology Station, clinical-reference viewers, workflow tools and administrative tools. Although the primary McKesson Radiology functionalities, such as DICOM study acquisition, storage, and archival, are intended to be installed and used within a hospital or health care facility environment, the viewing, reporting and administrative functions are intended for use both inside and outside of these settings by qualified healthcare practitioners.
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    K Number
    K043146
    Device Name
    HORIZON MEDICAL IMAGING
    Manufacturer
    MCKESSON MEDICAL IMAGING COMPANY
    Date Cleared
    2005-01-04

    (50 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MCKESSON MEDICAL IMAGING COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Horizon Medical Imaging is a medical image and information management system that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images). Horizon Medical Imaging is intended to connect to a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols. 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 megapixel resolution and meets other technical specifications reviewed and approved by FDA. Horizon Medical Imaging will simply perform normal image manipulations for grayscale and image contrast on mammographic images and will not perform image processing on mammographic images. Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologists, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft-copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft-copy diagnostic interpretation of mammographic images).
    Device Description
    Horizon Medical Imaging is software which when installed and run on Microsoft Windows 2000 and XP operating systems on commercially available IBM PC compatible computers, hardware components and peripherals, forms a medical image and information management system that receives, transmits, stores, retrieves, displays, prints and processes digital medical images, digital medical video, and associated medical information from various medical imaging systems. Its core components are: - High resolution color and grayscale workstations for primary diagnostic interpretation and secondary review of the medical images, video and related information. - Standard workstations for performing administrative functions of the system. - Servers for short-term and long-term storage of system data. - Servers for managing the distribution of system data. - Components for providing the communication channels between the system's core components and the various medical imaging systems. - Components for producing hardcopy of medical images and related information.
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