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510(k) Data Aggregation

    K Number
    K001833
    Date Cleared
    2000-09-28

    (104 days)

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

    PREFERENCE TREATMENT SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K983793
    Date Cleared
    1999-10-05

    (343 days)

    Product Code
    Regulation Number
    892.1000
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    PREFERENCE TREATMENT SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.
    • The indications for use of pReference Treatment System are expanded to include lesions requiring extracranial stereotactic radiotherapy or radiosurgery. These include hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors.
    • The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target with respect to implanted fiducials, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. This document is an FDA 510(k) clearance letter for the "pReference Treatment System," which is a treatment planning system. It outlines the device's indications for use and confirms its substantial equivalence to a predicate device.

    Therefore, I cannot populate the requested information. The document focuses on regulatory clearance rather than a detailed performance study.

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