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510(k) Data Aggregation

    K Number
    K241694
    Device Name
    ZeTTA PACS
    Date Cleared
    2025-01-31

    (233 days)

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

    Tae Young Soft Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ZeTTA PACS is intended for use in hospitals and diagnostic centers as a PACS to receive, store, retrieve, and display medical images from DICOM-compliant modalities, including CT, MRI, ultrasound, and radiographic devices. The system enables healthcare professionals to securely access and analyze diagnostic images over hospital networks. Typical users of ZeTTA PACS include trained professionals such as physicians, radiologists, and medical technicians. For mammography, only preprocessed DICOM for-presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specifications identified by FDA.
    Device Description
    ZeTTA PACS is a Windows-based Picture Archiving and Communication System (PACS) used in hospitals and diagnostic centers to receive, store, retrieve, distribute, and display medical images from various DICOMcompliant modalities, such as CT, MRI, ultrasound, and radiographic devices. This system supports the DICOM 3.0 standard and is designed to allow healthcare professionals to securely access and manage medical images over hospital networks. ZeTTA PACS supports more than two high-resolution monitors to facilitate efficient image interpretation. It provides advanced layout options, multi-worklist functionality, and DICOM GSPS (Grayscale Presentation State), enhancing diagnostic and analytical efficiency. Additionally, it offers image analysis tools such as ruler and angle, along with image manipulation features like windowing and zoom, enabling healthcare professionals to perform more accurate analyses. ZeTTA PACS integrates multiple medical imaging sources into a centralized solution, ensuring secure storage and management. It is useful across various medical fields such as radiology, and neurology. However, it does not provide diagnostic decision-making functions, and all diagnoses, treatments, and prescriptions must be made by qualified medical professionals. Furthermore, ZeTTA PACS does not support mobile devices and is designed for use in network-based desktop and workstation environments, ensuring stable and secure management of medical images.
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