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510(k) Data Aggregation

    K Number
    K222781
    Device Name
    Augmento
    Date Cleared
    2023-04-11

    (208 days)

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

    Deeptek Medical Imaging Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Augmento is a web-based PACS and radiology workflow management solution. It receives digital images and data from various DICOM compliant sources (i.e. CT scanners, ultrasound systems, RF Units, PET Units, computed & digital radiographic devices, secondary capture devices, imaging gateways and other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and/or across computer networks at distributed locations. Only preprocessed DICOM "for presentation" images can be interpreted for primary image diagnosis in mammography. Lossy compressed images and digitized film screens of mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specifications identified by the FDA. This system is meant to be used by trained and qualified medical professionals, e.g physicians, radiologists, nurses, and medical technicians.
    Device Description
    Augmento is a web based PACS and radiology workflow management solution. It is used to receive DICOM images from multiple systems, organize and store them into a centrally managed worklist and distribute the information across a web-based network. It is used by hospitals, imaging centers, radiologists, radiology professional services providers, and any user who requires and is granted access to the patient image, information, and reports. It is intended to be used as a platform for the diagnosis and analysis of radiology images by trained and qualified medical personnel such as radiologists, physicians, nurses, and medical technicians. It receives digital images and data from various DICOM-compliant sources (i.e., CT scanners, ultrasound systems, RF Units, computed & digital radiographic devices, secondary capture devices, imaging gateways, and other imaging sources). It provides MPR/MIP post-processing components that allow enhanced visualization to radiologists and assist them in diagnostic analysis and quantification of Computed Tomography (CT) and Magnetic Resonance (MR) images. When images are reviewed and used for diagnosis, it is the responsibility of the medical professional to determine if the images is suitable for clinical application. It provides optional integration with FDA-cleared 3rd party AI models. The solution only provides support for the visualization of outputs of 3rd party AI models "as-is". The safety and effectiveness of the 3rd party model is covered under the original 3rd party manufacturer's regulatory clearance. Augmento receives the output merely displays the simple output and the original image is always accessible. It is the responsibility of qualified medical practitioners to review the AI output, confirm the finding, and perform the diagnosis.
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