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510(k) Data Aggregation

    K Number
    K253784

    Validate with FDA (Live)

    Device Name
    3DICOM MD Cloud
    Manufacturer
    Singular Health Pty, Ltd.
    Date Cleared
    2026-01-08

    (43 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Age Range
    All
    Reference & Predicate Devices
    K222470,K233226
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K222470

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

    3DICOM MD Cloud is intended for use as a diagnostic and analysis tool for multi-modality medical images and their associated reports and information, enabling qualified healthcare professionals from hospitals, imaging centres, radiologists, and reading practices to view patient images, documents, and related data. 3DICOM MD Cloud enables qualified users to manipulate medical images, create markups, and perform measurements using a range of tools.

    3DICOM MD Cloud is not intended for diagnostic use with mammography images. Usage for mammography is for reference and referral only. 3DICOM MD Cloud is not intended for diagnostic use on mobile devices.

    Device Description

    3DICOM MD Cloud is a software as a medical device that provides diagnostic viewing and analysis of multi-modality DICOM images in a secure, web-based, cloud/server-hosted environment. Authorized users access studies from site-provisioned cloud storage sources and perform 2D multi-planar viewing (MPR) and 3D visualization, apply window/level and other standard adjustments, make 2D measurements and annotations, generate a DICOM-structured report summarizing tracked measurements, and export snapshots/measurement tables. The device does not generate diagnoses or provide automated clinical interpretation.

    AI/ML Overview

    N/A

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