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510(k) Data Aggregation

    K Number
    K012779
    Device Name
    ICONNECTION 3D
    Manufacturer
    HINNOVATION, INC.
    Date Cleared
    2001-11-02

    (74 days)

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

    HINNOVATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    iConnection 3D is a software application intended for integrated processing and distribution of 2D and 3D digitized data derived from CT and MRI (and others) scans for use by radiologists, clinicians, and other professionals to acquire, process, render, review, store, print, and distribute DICOM 3.0 compliant images utilizing standard PC hardware with MS 98, NT, or MS 2000 operating systems. CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
    Device Description
    iConnection 3D is a picture archiving and communications system as described in 21 CFR 892.2050.
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