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510(k) Data Aggregation

    K Number
    K973864
    Device Name
    COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO
    Manufacturer
    PAUSCH CORP.
    Date Cleared
    1998-06-17

    (251 days)

    Product Code
    IZF,IYB,IZZ
    Regulation Number
    892.1740
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    : March 27, 1997 Received: May 14, 1997 Regulatory class: II 21 CFR 892.1740/Procode: 90 IZF 21 CFR 892.1770

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

    To be used for radiography and radiographic tomography examinations as prescribed by a licensed physician.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "Combi Elevator-2 & Combi Elevator-2 Microtom." It indicates that the device has been found substantially equivalent to previously marketed devices. However, this document does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    The letter focuses solely on the regulatory approval and indications for use. Therefore, I cannot provide the requested information based on the provided text.

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