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510(k) Data Aggregation

    K Number
    K202068
    Device Name
    The AIO Solution 3.0
    Manufacturer
    Orfit Industries NV
    Date Cleared
    2020-08-14

    (18 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orfit Industries NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AIO Solution 3.0 is a positioning and immobilization system to set-up and reproduce the supine and prone position of belly & pelvic patients and the prone position of breast patients during radiation therapy.
    Device Description
    The AIO Solution 3.0 with accessories provides the immobilization and positioning system necessary to set-up and reproduce the position of a patient for supine and prone belly & pelvic treatments or prone breast treatments in radiation therapy. For belly & pelvic treatments, the AIO solution 3.0 base plates (already cleared: K191158) can be used in combination with the green AIO 3.0 belly & pelvic positioning cushions and accessories. Depending on the anatomy of the patient, 2 different sizes of belly inserts are available to make sure the intestines can be pulled out of the treatment area when in prone position. The arms of the patient are positioned above the head to bring them out of the treatment field. A full belly insert should be used in supine position while the arms of the patient can be positioned on the chest to bring them out of the treatment field. The legs of the patient are supported by the grey AIO 3.0 knee & leg positioning cushions and/or the AIO 3.0 indexable feet support (already cleared; K191158). For increased precision, the set-up can be combined with an Orfit thermoplastic EFFICAST mask. For prone breast treatments, the AIO solution 3.0 base plates (already cleared; K191158) can be used in combination with the yellow AIO 3.0 prone breast positioning cushions and accessories. The arms of the patient are positioned above the head to bring them out of the treatment field. The legs of the patient are supported by the grey AIO 3.0 knee & leg positioning cushions (already cleared; K191158). For increased precision, the set-up can be combined with an Orfit thermoplastic EFFICAST mask.
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    K Number
    K200282
    Device Name
    Orfit Aerial Couchtop
    Manufacturer
    Orfit Industries NV
    Date Cleared
    2020-04-08

    (64 days)

    Product Code
    LHN
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orfit Industries NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aerial Couchtop for proton therapy is intended to support, position and immobilize patients during proton radiotherapy treatments.
    Device Description
    Not Found
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    K Number
    K191158
    Device Name
    The AIO Solution
    Manufacturer
    Orfit Industries NV
    Date Cleared
    2019-08-06

    (97 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orfit Industries NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AIO Breast and Lung Board Solution is a positioning and immobilization system to set-up and reproduce the supine position of a breast or lung patient during radiation. The AIO Head and Neck Solution is indicated to aid in supporting the knees or ankles of patients undergoing radiation therapy in the supine or prone position. The device is also used during image acquisition to support treatment planning.
    Device Description
    Not Found
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    K Number
    K171734
    Device Name
    HP PRO Positioning Device
    Manufacturer
    Orfit Industries NV
    Date Cleared
    2017-07-25

    (43 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orfit Industries NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HP PRO Positioning Device is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery and treatment with protons.
    Device Description
    The HP PRO Positioning Device is used by first attaching the base plate to the couch top utilizing the appropriate indexing. Then the health care provider positions the immobilization devices on to the HP PRO Positioning Device. Next the patient is helped onto the couch and positioned onto HP PRO Positioning Device in the appropriate immobilization device. An example of an immobilization device is the overlay base plate of the Proton Immobilization Solution. The HP PRO Positioning Device is a device that assists in the proper positioning and repositioning of patients for radiation therapy and radiosurgery with protons. It is an accessory to the Proton Immobilization Solution. The HP PRO Positioning Device is typically attached to the treatment table and supports the patient during treatment. The proposed HP PRO Positioning Device is essentially an extension of the treatment table. The HP PRO Positioning Device is made up of 4 components: Base Plate (PMMA and Carbon Fiber), Interface (Aluminum), Indexing Pins (POM (Polyoxymethylene)), and Sheet Screws (Stainless Steel).
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    K Number
    K162355
    Device Name
    Raycast MammoRx Carbon Fibre Breast Board
    Manufacturer
    Orfit Industries NV
    Date Cleared
    2016-11-22

    (91 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orfit Industries NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Raycast MammoRx Carbon Fibre Breast Board is a positioning and immobilization system to set-up and reproduce the supine position of a breast patient during radiation therapy.
    Device Description
    Not Found
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    K Number
    K162862
    Device Name
    Raycast High Precision Lung Board Solution
    Manufacturer
    Orfit Industries NV
    Date Cleared
    2016-11-09

    (28 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orfit Industries NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Raycast High Precision Lung Board Solution is a patient positioning device intended to be used for the positioning and re-positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases. It is intended to be used by or under the direction of a licensed physician.
    Device Description
    The Raycast High Precision Lung Board is used to position the patient supine on the treatment couch with the arms lifted above the head. This will keep the arms outside of the treatment field, which is the thorax in this case. The Raycast High Precision Lung Board is attached to the treatment couch with a 2-vin indexing bar in order to reproduce the same position each day. The Raycast High Precision Lung Board should be fully supported by the treatment couch. Then the patient is asked to lie down on the couch with his head in a head support that is attached to the Raycast High Precision Lung Board. Once the patient is lying down, he can lift up his arms until the elbows rest against the 'wings' of the board and the hands can reach the T-shaped handgrip. The position of the T-shaped handgrip can be adjusted both in height and length according to the patient's anatomy. To adjust the height of the handgrip, pull the white knob on the side and move the grip pole up or down. To adjust the length of the handgrip, pull the white knob at the cranial side and slide the handgrip more caudally or cranially. Various head supports can be placed on the Raycast High Precision Lung Board depending on the physician's preference. The standard set-up will be with an Orfit Head Support, but it is also possible to use a Silverman or Timo Head Support which they might already have available in their department. Once the patient is set-up correctly, the arms should not be treatment field anymore, which is the thorax area in this case. This allows the physician to irradiate the thorax from various angles, including laterally without passing through the arms of the patient. The Raycast High Precision Lung Board itself will not be in the treatment field and as such will not be irradiated through.
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    K Number
    K151207
    Device Name
    Proton Immobilization Solution
    Manufacturer
    ORFIT INDUSTRIES NV
    Date Cleared
    2015-07-28

    (83 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORFIT INDUSTRIES NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Proton IMMOBILIZATION Solution is indicated to assist in the proper positioning and repositioning of patients for radiation therapy and radiosurgery and treatment including electron, photon, and proton treatments.
    Device Description
    Not Found
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    K Number
    K141787
    Device Name
    SAGITTILT
    Manufacturer
    ORFIT INDUSTRIES NV
    Date Cleared
    2014-08-07

    (36 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORFIT INDUSTRIES NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SAGITTL is indicated to assist in the proper positioning and re-positioning of patients for radiation therapy and radiosurgery simulation and treatment including electron, photon and proton treatments.
    Device Description
    Not Found
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    K Number
    K131795
    Device Name
    NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS
    Manufacturer
    ORFIT INDUSTRIES NV
    Date Cleared
    2013-09-26

    (100 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORFIT INDUSTRIES NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NANOR and NANOR/EFFICAST Hybrid Thermoplastic materials are used to retain and reproduce a patient's position during radiation therapy.
    Device Description
    Not Found
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