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510(k) Data Aggregation

    K Number
    K960382
    Date Cleared
    1996-04-17

    (83 days)

    Product Code
    Regulation Number
    892.2020
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KODAK Digital Science Medical Image Manager is an extension of the KODAK Health Sciences Imagelink System with the intended use to be used as a network gateway to a host of image management and printing devices.
    The KODAK Digital Science Medical Image Manager will provide network access for both point -to - point and network capable image and information sources. The Image Manager will provide a value added service to point - to - point devices by adding services including routing to multiple destinations and access to multiple printers. However, evaluation of soft copy or hard copy output provides adequate opportunity for competent human intervention. PACS are not represented to be used in supporting or sustaining human life, nor do they represent a potential for unreasonable risk of illness or injury.

    Device Description

    The general hardware configuration of the KODAK digital Science Medical Imager contains the following major components:
    -Power Supply
    -Main System Circuit Board
    -Hard Dick
    -Internal Removable Media
    -Keypad
    Optional Accessories:
    -Keypad Accessories
    -Mini-keypad
    -Microphone
    -Modality Store Connection
    -Keyboard
    -Bar Code Reader
    -Magnetic Stripe Reader

    AI/ML Overview

    This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The provided text is a 510(k) premarket notification for the KODAK Digital Science Medical Image Manager, focusing on its general information, intended use, and a comparison of its features with a previous Kodak product. It details hardware components, power requirements, environmental conditions, acquisition unit specifications (disk storage, network capability, video/digital inputs, capture/store times), and reader unit specifications (inputs, outputs, image presentation options).

    Therefore, I cannot provide the requested information.

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