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510(k) Data Aggregation

    K Number
    K223484
    Device Name
    IGAR System (1001.A)
    Date Cleared
    2023-07-20

    (244 days)

    Product Code
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Insight Medbotics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IGAR System is intended to acquire magnetic resonance (MR) images of the breast anatomy and permits access to the breast for biopsy and localization procedures. A front breast restraint immobilizes the patient's breast to permit three-dimensional MR imaging to identify the location of the breast lesion(s) for the purposes of selecting a target for biopsy. The IGAR System guides a breast biopsy tool to the target location of the breast from which a biopsy can be obtained. The IGAR System is intended to be used by qualified professionals.
    Device Description
    The IGAR System is a tool-positioning system for enabling accurate MR-quided breast biopsies. The IGAR System is designed to provide biopsy tool guidance and accurate targeting of lesions in the breast while the patient is in the MRI room– this creates the ability to "see and evaluate" within a single session. The system consists of the following components: Workstation, Patient Support, Manipulator, Pendant, Control Cart. The IGAR System integrates with an FDA-cleared MRI system from GE, 3 Tesla (3T) GE Discovery™ MR750 - 60cm (Bore size).
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