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    K Number
    K012138
    Device Name
    MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)
    Manufacturer
    CHROMAVISION MEDICAL SYSTEMS, INC.
    Date Cleared
    2002-09-30

    (447 days)

    Product Code
    MYA, MXZ
    Regulation Number
    864.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHROMAVISION MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Automated Cellular Imaging System (ACIS) device is intended to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape. In this software application the ACIS device is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffinembedded tissue specimens immunohistochemically stained for Estrogen Receptors or Progesterone Receptors (ER/PR). It is indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer.
    Device Description
    Automated Cellular Imaging System (ACIS) for detection of ER/PR
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    K Number
    K984188
    Device Name
    AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
    Manufacturer
    CHROMAVISION MEDICAL SYSTEMS, INC.
    Date Cleared
    1999-07-28

    (247 days)

    Product Code
    JOY
    Regulation Number
    864.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHROMAVISION MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACIS Automated Cellular Imaging System is intended for & In Vitro Diagnostic Uses as an aid to the pathologist in the classification and counting of cells of interest based on particular color, size and shape.
    Device Description
    The Automated Cellular Imaging System (ACIS) device is an automated intelligent microscope cell locating device that detects cells (objects) of interest, by color and pattern recognition techniques. The system consists of software resident in computer memory and includes keyboard, color monitor, microscope, printer, and automatic slide handlinq equipment controlled and operated by a health care professional for interpretation and diagnosis.
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