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510(k) Data Aggregation

    K Number
    K990248
    Device Name
    DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION
    Manufacturer
    DICOMIT IMAGING SYSTEMS CORP.
    Date Cleared
    1999-04-16

    (80 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K951925,K961459,K964617
    Why did this record match?
    Reference Devices :

    K951925, K961459, K964617

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

    The DICOMIT Dicom Image Manager medical image management system is intended for acceptance, transfer, display, storage and digital processing of medical images. The software component provides functions for performing operations related to image manipulation.

    The "3D ROI" software option enables the device to display and manipulate an adjunctive 3D volume image created with data from a diagnostic ultrasound scanning procedure.

    Device Description

    The software changes described in this submission enable the DICOMIT Dicom Image Manager - with 3D-visualization software module to store in memory, multiple sequential ultrasound images when using a standard ultrasound transducer during any standard ultrasound scanning procedure. These images can then be rendered as a 3D image that can be displayed and manipulated in "windows" on the monitor.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the DICOMIT Dicom Image Manager - Addition of 3D Visualization Software Module. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.

    The document focuses on:

    • Identifying the submitter and device.
    • Classifying the device and its intended use.
    • Comparing it to predicate devices to establish substantial equivalence.
    • The FDA's decision to clear the device based on substantial equivalence.

    Therefore, I cannot provide the requested table and details because the information is not present in the given text. The FDA clearance is based on substantial equivalence to existing devices, implying that detailed performance studies might not have been required for this specific 510(k) submission, as the fundamental technology and intended use were deemed similar to devices already on the market.

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