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510(k) Data Aggregation

    K Number
    K223133
    Device Name
    VisiRad XR
    Manufacturer
    Date Cleared
    2023-08-03

    (304 days)

    Product Code
    Regulation Number
    892.2070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Imidex Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VisiRad XR is a computer-aided detection (CADe) device intended to identify and mark regions of interest that may be suspicious for lung nodules and masses on chest radiographs. It identifies features associated with pulmonary nodules and masses from 6-60mm in size. Detection of suspicious findings by VisiRad XR is intended as an aid only after the physician has performed an initial interpretation; it is not intended to replace the review by a qualified radiologist and is not intended to be used for trage or to make or confirm a diagnosis. The intended patient population for VisRad XR consists of patients >21 years of age on whom chest radiographs have been acquired in an outpatient or emergency department setting.
    Device Description
    VisiRad XR is a computer aided detection (CADe) software as a medical device (SaMD) product intended to detect lung nodules and masses from 6-60mm in chest radiographs. VisiRad XR takes DICOM images as input, utilizes machine learning algorithms to detect suspicious regions and outputs a secondary DICOM with annotated regions of interest (ROIs). VisiRad XR's output secondary DICOM includes text that it was analyzed by VisiRad XR and a link to the user manual. If no ROIs are detected by VisiRad XR, the returned secondary DICOM states "No Nodules/Masses Found". VisiRad XR is intended to be used as a second-read only after the clinician has performed their initial interpretation. The secondary DICOM does not overwrite or replace the primary radiograph, it is returned such that it hangs, using standard DICOM hanging protocol, behind the primary image.
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