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510(k) Data Aggregation

    K Number
    K121479
    Device Name
    AIM
    Manufacturer
    INNEROPTIC TECHNOLOGY, INC
    Date Cleared
    2012-09-13

    (118 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNEROPTIC TECHNOLOGY, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AM is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a stereoscopic computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualizing such procedures.
    Device Description
    AM is an accessory to ultrasound systems that provides guidance for the placement of needles or needle-like rigid objects, such as biopsy needles and ablation probes. The system enables a physician to accurately place a needle into a target anatomical structure by overlaying the image of the needle and its predicted future path on the ultrasound image of the internal organs in real time on a stereo monitor, for a "3D" effect (cf. IMAX 3D theaters). AIM consists of four (4) principal components: an electromagnetic position tracking system; tracking sensors and mounts for the ultrasound transducer and the needle; custom guidance software installed on a computer; and a stereoscopic monitor with passive glasses for viewing the monitor.
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    K Number
    K083728
    Device Name
    INVISION SYSTEM
    Manufacturer
    INNEROPTIC TECHNOLOGY, INC
    Date Cleared
    2009-08-12

    (239 days)

    Product Code
    IYO, OEW
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNEROPTIC TECHNOLOGY, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InVision System is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a stereoscopic computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualizing such procedures.
    Device Description
    The InVision System is an accessory to ultrasound systems that provides guidance for the placement of needle-like rigid objects, such as biopsy needles and ablation probes. The system enables a physician to accurately place a needle into a target anatomical structure by overlaying the image of the needle and its predicted future path on the ultrasound image of the internal organs in real time on a stereo monitor, for a "3D" effect (cf. IMAX 3D theaters). The InVision System consists of four (4) principal components: - a passive infrared position tracking system; (1) - (2) tracking mounts for the ultrasound transducer and the needle; - custom guidance software installed on a computer; and (3) - (4) a stereoscopic monitor with passive glasses for viewing the monitor.
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