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510(k) Data Aggregation

    K Number
    K222470
    Device Name
    3Dicom MD
    Date Cleared
    2022-10-25

    (70 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Singular Health Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    3Dicom MD software is intended for use as a diagnostic and analysis tool for diagnostic images for hospitals. imaging centers, radiologists, reading practices and any user who requires and is granted access to patient image, demographic and report information. 3Dicom MD displays and manages diagnostic quality DICOM images. 3Dicom MD is not intended for diagnostic use with mammography images. Usage for mammography is for reference and referral only. 3Dicom MD is not intended for diagnostic use on mobile devices. Contraindications: 3Dicom MD is not intended for the acquisition of mammographic image data and is meant to be used by qualified medical personnel.
    Device Description
    3Dicom MD is a software application developed to focus on core image visualization functions such as 2D multi-planar reconstruction, 3D volumetric rendering, measurements, and markups. 3Dicom MD also supports real-time remote collaboration, sharing the 2D & 3D visualization of the processed patient scan and allowing simultaneous interactive communication modes between multiple users online through textual chat, voice, visual aids, and screen-sharing. Designed to be used by radiologists and clinicians who are familiar with 2D scan images, 3Dicom MD provides both 2D and 3D image visualization tools for CT, MRI, and PET scans from different makes and models of image acquisition hardware.
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