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510(k) Data Aggregation

    K Number
    K252174
    Device Name
    AquaCast Mask
    Manufacturer
    Blessing Cathay Corporation
    Date Cleared
    2025-09-03

    (54 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K120335
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AquaCast Mask is a device used for the positioning and immobilization of patient's head undergoing or receiving a course of external beam radiation therapy for the treatment of cancer. Thermoplastic Mask is intended as a single-patient reusable device only and are not sterile.

    Device Description

    AquaCast Mask is used for the positioning and immobilization of patient's head undergoing or receiving a course of external beam radiation therapy for the treatment of cancer. The low temperature thermoplastic mask is made of AquaCast polycaprolactone sheet for patient immobilization. Heat at a temperature of 150°F ~ 158°F is applied to the sheet to soften it and mold it to the shape of the patient anatomy. The perforated thermoplastic is pre-mounted to a non-patient contacting frame to interface with the user's existing support hardware and hold the patient's head in a fixed position for radiation therapy treatments

    AI/ML Overview

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