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510(k) Data Aggregation

    K Number
    K970464
    Date Cleared
    1997-09-05

    (210 days)

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

    P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1

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

    The indications for use of pReference Treatment Planning Software 1.1 are such intracranial diseases as gliomas, neuromas, meningiomas, astrocytomas, arteriovenous malformations, and metastatic carcinomas.

    The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) clearance letter and an Indications for Use statement for the "pReference Treatment Planning Software 1.1". These documents confirm the device's clearance for marketing based on substantial equivalence to a predicate device, but they do not contain information about acceptance criteria or specific study details proving the device meets those criteria, nor do they include performance metrics like those typically found in a clinical study report.

    Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need a clinical study report, a validation report, or a similar performance evaluation document for the pReference Treatment Planning Software 1.1.

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