LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K062788
    Device Name
    COLLIMATOR, MODEL M-38
    Manufacturer
    UMI INTERNATIONAL
    Date Cleared
    2006-12-28

    (101 days)

    Product Code
    KPW
    Regulation Number
    892.1610
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    UMI INTERNATIONAL

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

    A diagnostic x-ray beam-limiting device intended to restrict the dimension of a diagnostic x-ray field by limiting the size of the primary x-ray beam coming from x-ray system.

    Device Description

    Collimator (manual drive) – a beam limiting device

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a Collimator (manual drive) and does not contain information about acceptance criteria or a study proving its performance. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1