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510(k) Data Aggregation

    K Number
    K993338
    Device Name
    INTEGRATED DIGITAL MEDICAL RECORD (IDMR)
    Manufacturer
    Date Cleared
    1999-12-29

    (85 days)

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

    IBM ISRAEL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IBM Integrated Digital Medical Record (IDMR) provides integrated access to digital patient folders and manages digital information flow in a networked health care environment. It integrates all sources of multimedia patient data into a single patient folder, combining demographic, clinical, and radiological information.
    Device Description
    The IDMR system is UNIX and Windows/NT based, with UNIX (IBM RS/6000 and AIX) servers and clients, and Windows/NT clients. IDMR uses standard IBM hardware and software (RISC System/6000, AIX, IBM/PC, ADSM) components. IDMR uses the industry standard structured query language (SQL) database. The system currently supports IBM DB2/6000 and Oracle databases. IDMR is designed to operate over local and wide area networks. Standard transmission control protocol/Internet protocol (TCP/IP) is used throughout the communication networks. The communication systems supported include (but are not limited to) token ring, Ethernet, fiber distributed data interface (FDDI), asynchronous transfer mode (ATM), and integrated services and digital network (ISDN). IDMR is implemented using the C and C++ programming languages. The system implements state-of-the-art client/server technology and enables seamless addition of hardware modules. The system servers (file management system (FMS), data interface server (DIS), storage management system (SMS) can be installed on larger central UNIX machines or can be distributed to smaller machines in various departments. IDMR supports DICOM 3.0 standard for data model, and interconnectivity protocol.
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