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510(k) Data Aggregation

    K Number
    K060137
    Device Name
    KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
    Manufacturer
    EASTMAN KODAK COMPANY
    Date Cleared
    2006-03-16

    (56 days)

    Product Code
    MQB,MOB
    Regulation Number
    892.1680
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KODAK ECLIPSE IMAGE PROCESSING SOFTWARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CR Systems are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiography applications. This excludes mammography applications for the Kodak Ektascan Storage Phosphor Reader and the Kodak Eclipse Image Processing Software in the United States.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. It is a letter from the FDA to Eastman Kodak Company regarding the 510(k) premarket notification for "Kodak Eclipse Image processing software," confirming its substantial equivalence to a predicate device.

    Therefore, I cannot fulfill your request for information about acceptance criteria and study details based on the given input.

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