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510(k) Data Aggregation

    K Number
    K081836
    Device Name
    CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM
    Manufacturer
    CARESTREAM HEALTH,INC.
    Date Cleared
    2008-07-30

    (30 days)

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

    CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    This looks like a 510(k) clearance letter from the FDA. While it confirms the device's substantial equivalence to a predicate device, it does not contain the detailed acceptance criteria or a study summary that proves the device meets those criteria.

    A 510(k) clearance primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It typically relies on comparisons of technological characteristics and, sometimes, performance data to establish this equivalence, rather than setting specific acceptance criteria and then presenting a study to prove those criteria are met in the same way a PMA (Pre-Market Approval) or a more rigorous clinical trial submission might.

    Therefore, I cannot provide the requested information from this document. The information in this letter is insufficient to answer the prompt.

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