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510(k) Data Aggregation

    K Number
    K241975
    Device Name
    SERV MEDICAL CDSS
    Date Cleared
    2025-03-17

    (255 days)

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

    Serv Medical Pte. Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SERV MEDICAL CDSS is an image processing software package to be used by trained professionals, including, but not limited to physicians and medical technicians. The software runs on standard "off-the-shelf" hardware and can be used to perform image viewing, processing and analysis of images. Data and images are acquired through DICOM compliant imaging devices. SERV MEDICAL CDSS provides viewing and analysis capabilities for imaging datasets acquired with DSA (Digital Subtraction Angiography). SERV MEDICAL CDSS is not intended for mobile diagnostic use.
    Device Description
    SERV MEDICAL CDSS is a medical image visualization and processing software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server. SERV MEDICAL CDSS allows for the visualization, analysis and post-processing of DICOM compliant DSA images which, when interpreted by a trained physician or medical technician, may yield information useful in clinical decision making. SERV MEDICAL CDSS provides a wide range of basic image viewing, processing and manipulation functions, through multiple output formats. The software is used to visualize large vessels from DSA imaging. SERV MEDICAL CDSS can connect with other DICOM-compliant devices, for example to transfer DSA scans from a Picture Archiving and Communication System (PACS) to SERV MEDICAL CDSS software for processing.
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