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510(k) Data Aggregation

    K Number
    K964460
    Device Name
    THE ROBOLITE
    Manufacturer
    SHAI SYG MOTION AND INNOVATIONS, LTD.
    Date Cleared
    1997-01-24

    (78 days)

    Product Code
    JQP
    Regulation Number
    862.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHAI SYG MOTION AND INNOVATIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ROBOLITE is an automatic needle guidance system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions.
    Device Description
    The ROBOLITE is an automatic needle guidance system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions. The ROBOLITE I S an attachment to and is mounted on a parent mammography system. It comprises a robotic biopsy unit and a film read out and motor control evaluation unit. After creating a stereotactic exposure of a previously detected breast lesion, the Robolite drives a needle holder along three orthogonal axes so that the needle penetrates the precise location of the lesion. The ROBOLITE can be used for fine for core biopsy by using the reqular needle aspiration (FNA) or carrier with a biopsy gun. needle with either plain film with a The ROBOLITE can be used X-ray or digital camera.
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    K Number
    K961849
    Device Name
    THE ROBOGUIDE
    Manufacturer
    SHAI SYG MOTION AND INNOVATIONS, LTD.
    Date Cleared
    1996-08-21

    (100 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHAI SYG MOTION AND INNOVATIONS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The ROBOGUIDE is an automatic needle guidanc system that provides means for accurate positioning of a biopsy needle of a mammography system, to enable accurate penetration to sites of detectable breast lesions. The Roboguide is an attachment to and is mounted on a parent mammography system. It comprises a robotic biopsy unit and a film read out and motor control evaluation unit. After creating a stereotactic exposure of a previously detected breast lesion, the Roboguide drives a needle holder along three orthogonal axes so that the needle penetrates the precise location of the lesion. The Roboguide can be used for fine needle aspiration (FNA) or tor core biopsy by interchanging its aspiration needle carrier with a biopsy gun holder carrier. The Roboguide can be used with either plain film X-ray or with a digital camera.
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