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510(k) Data Aggregation

    K Number
    K042781
    Device Name
    IPACS CARDIO
    Manufacturer
    REAL TIME IMAGE INC.
    Date Cleared
    2004-10-19

    (13 days)

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

    REAL TIME IMAGE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    iPACS CARDIO™is intended for the manipulation, display, and distribution of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. The device assists Cardiology surgeons when doing preoperative planning and post-operative follow-up. Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.
    Device Description
    iPACS CARDIO™ is a software product that is added to the iPACS PRISMI™ device (K030751) and displays and manages various digital images and Cine objects in a Picture Archive and Communication System (PACS) environment and is intended to assist cardiology surgeons when doing preoperative planning and post-operative follow-up. iPACS CARDIO™ also includes various tools and can access additional tools within iPACS Prism.
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    K Number
    K041366
    Device Name
    IPACS ORTHO
    Manufacturer
    REAL TIME IMAGE INC.
    Date Cleared
    2004-06-08

    (15 days)

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

    REAL TIME IMAGE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    iPACS ORTHO™is intended for the manipulation, displaying, and distribution of medical images. It can show images from different modalities and interfaces to medical images. It one and printing devices using DICOM or similar interface standards. The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up. Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.
    Device Description
    iPACS ORTHO™ handles and displays various objects in a Picture Archive and Communication System (PACS) environment and is intended to assist orthopedic surgeons when doing preoperative planning and post-operative follow-up. The device is used to overlaying prosthesis templates on radiological images, tools for repositioning the templates, and tools for measurements in the images.
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    K Number
    K030751
    Device Name
    IPACS PRISM
    Manufacturer
    REAL TIME IMAGE INC.
    Date Cleared
    2003-05-29

    (80 days)

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

    REAL TIME IMAGE INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    iPACS Prism™ from RealTimeImage Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
    Device Description
    iPACS Prism™ is a complete PACS solution designed to be Internet friendly for easy deployment over local area networks and/or wide area networks. The system is modular and will be offered under different brand names depending upon customer implementation and which system components of iPACS Prism are needed. iPACS™ handles various images and data objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.
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