Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K250970
    Device Name
    Marie
    Manufacturer
    Leo Cancer Care
    Date Cleared
    2025-07-25

    (116 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Leo Cancer Care

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K231612
    Device Name
    Eve Patient Positioner System
    Manufacturer
    Leo Cancer Care
    Date Cleared
    2024-05-07

    (340 days)

    Product Code
    JAI
    Regulation Number
    892.5770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Leo Cancer Care

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Leo Cancer Care Patient Positioning Subsystem is indicated for precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate beam therapy treatment delivery device.
    Device Description
    The Leo Cancer Care (LCC) Patient Positioning Subsystem (EVE) is designed to deliver precise positioning of a patient when combined with an external Beam Therapy device, to provide the intended treatment therapy prescribed for patients requiring radiation treatments. The Patient Positioning System has 6 degrees of freedom to provide full alignment capability for a patient treatment session, with the patient being located in an upright position. The Eve Patient Positioning Subsystem is held in a static position for the duration of the external Beam Therapy System radiation exposure. After the beam delivery has been completed, the patient positiong subsystem is then aligned to the next patient position required by the treatment system and the process repeated for the required series of different beam placements to achieve the full prescribed treatment delivery for the patient.
    Ask a Question

    Page 1 of 1