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510(k) Data Aggregation

    K Number
    K111731
    Device Name
    MOLECULAR BREAST IMAGING SOFTWARE
    Manufacturer
    GAMMA MEDICA-IDEAS INCORPORATED
    Date Cleared
    2011-09-15

    (87 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K002782,K010726,K080961
    Why did this record match?
    Device Name :

    MOLECULAR BREAST IMAGING SOFTWARE

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

    The Molecular Breast Imaging Software is designed to acquire nuclear medicine image data from the Gamma Medica-Ideas LumaGEM™ gamma camera systems. The Molecular Breast Imaging Software allows images and data to be stored, communicated, processed, analyzed and displayed on a compatible workstation.

    Device Description

    The Gamma Medica-Ideas Molecular Breast Imaging Software ("MBI Software") is a software tool intended to display and process breast images captured with the Gamma Medica-Ideas LumaGEM" gamma camera systems. The MBI Software contains functions of study display, Gray and Inverse Gray Images, Window/Level changes, Measuring Tool, image processing, and Save, Sum, and Reload (both raw and processed). Image processing is based on pixel-by-pixel analysis and algorithmic filters applications. The MBI Software application supports simultaneous display of multiple images, allowing the user to visualize several angles of the imaged breast tissue at once. The MBI Software is compatible with DICOM and other formats.

    AI/ML Overview

    This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily describes a 510(k) premarket notification for the Molecular Breast Imaging Software, focusing on its intended use, product description, and substantial equivalence to predicate devices. The "Testing in Support of Substantial Equivalence Determination" section only broadly mentions "Software verification and validation" and "Direct comparison testing between the subject device and the original application" without providing any specific criteria, methods, or results of these tests.

    Therefore, I cannot populate the requested table or answer the specific questions about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.

    Key takeaway from the provided text: The submission relies on demonstrating substantial equivalence to predicate devices, and the "testing" mentioned is not detailed enough to provide the requested information.

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