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510(k) Data Aggregation

    K Number
    K971367
    Device Name
    BRAINSCAN CONFORMAL RT MODULE
    Manufacturer
    BRAINLAB, AG
    Date Cleared
    1997-10-27

    (196 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BRAINSCAN CONFORMAL RT MODULE

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

    Computer aided planning of static and dynamic conformal radiation therapy treatments. The BrainSCAN Conformal RT Module is intended to plan radiation therapy treatments of lesions using conformal block collimators that are shaped (i.e. contour molded) to the outline of the lesion in beam's eye view or using a multileaf collimator. Using shaped collimators helps to deliver radiation exactly to the target volume while sparing surrounding healthy tissue and critical structures from accessing radiation.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria, study details, or performance of the BrainLab BrainScan Conformal RT Module. The document is an FDA 510(k) clearance letter from 1997, which confirms that the device is substantially equivalent to previously marketed devices for specific indications for use.

    Therefore, I cannot provide the requested table and study details based on the given input.

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