LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040982
    Device Name
    COLOR LCD MONITOR, MODEL RADIFORCE R12
    Manufacturer
    EIZO NANAO CORPORATION
    Date Cleared
    2004-05-13

    (28 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    COLOR LCD MONITOR, MODEL RADIFORCE R12

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

    RadiForce R12 is intended to be used in displaying for diagnosis of X-ray or MRI, etc. The product is not intended for use with a digital mammography system.

    Device Description

    Color LCD Monitor, RadiForce R12

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a medical device: an Eizo Nanao Corporation Color LCD Monitor, RadiForce R12.

    Based on the provided text, there is NO information available regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

    This letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not contain the detailed technical or clinical study data that would typically define acceptance criteria or describe a study's methodology and results.

    The "Indications for Use" section (Page 2) states: "RadiForce R12 is intended to be used in displaying for diagnosis of X-ray or MRI, etc. The product is not intended for use with a digital mammography system." This specifies the intended clinical application but does not provide performance metrics or acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1