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510(k) Data Aggregation

    K Number
    K220910
    Device Name
    Medical image processing software
    Date Cleared
    2022-08-11

    (135 days)

    Product Code
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Hangzhou Deepwise **& league of PHD Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DW-CACTAS is a medical image processing software, combining digital image processing and visualization tools (multiplanar reconstruction (MPR) think, maximum intensity projection(MP) thin/thick, inverted MIP thinkthick, volume rendering technique (VRT), curved planar reformation (CPR)), this software is used for post-processing of coronary CT angiography images.
    Device Description
    Medical image processing software (DW- CACTAS) is a network system management and image processing software based on local storage service. The software obtains image data from medical image equipment through image network transmission and storage technology, and stores data in the server. Through the information system management function module and image processing module, medical institution can transmit, store, query, browse, manage and process image data. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, maximum intensity projection(MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT), curved planar reformation (CPR)), the DW- CACTAS is used for post-processing of coronary CT angiography images. The data transmission of the software follows the HTTP transmission protocol and DICOM network protocol, and supports the DICOM3.0 standard data transmission interface. The medical image storage format is DICOM.
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