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510(k) Data Aggregation

    K Number
    K250429
    Device Name
    DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set
    Manufacturer
    MacroMedics BV
    Date Cleared
    2025-03-19

    (33 days)

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

    MacroMedics BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    All devices apart from Handgrips HNS, set/2 (111730): Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment. Handgrips HNS, set/2 (111730): Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
    Device Description
    The DSPS-Prominent baseplate, MR is an MR Safe baseplate which supports the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The device features a cantilevered frame on the cranial side which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is fixed to the couch strips. A Coil Reference Tool accessory is available. The DSPS-Prominent baseplate supports the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The device features a cantilevered frame on the cranial side which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is fixed to the couch using couch strips. Optional accessory hand grips are available. The DSPS-Prominent cradles support the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The devices feature a cantilevered frame which facilitates the use of both facial and occipital head, neck and shoulder masks and head only masks. The device is required to be fixed to a baseplate. The DSPS-Prominent Masks are facial and occipital thermoplastic masks which are used together with a DSPS-Prominent baseplate or cradle to facilitate accurate positioning and immobilization of the head and neck or head, neck and shoulder region of the patient. The Masks which do not support the positioning of the shoulders are termed 'head only' masks. Shoulder Profile and Shim accessories are available.
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    K Number
    K222977
    Device Name
    DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip
    Manufacturer
    MacroMedics BV
    Date Cleared
    2023-02-17

    (142 days)

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

    MacroMedics BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DSPS-Prominent™ Masks, DSPS-Prominent™ Baseplate, MR: Positioning and immobilization of the patient during radiotherapy. This includes positioning and immobilization of the patient during image acquisition to support treatment such as in Magnetic Resonance (MR) and Computed Tomography (CT) Imaging Systems. CouchStrip: Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
    Device Description
    DSPS-Prominent Masks: The DSPS-Prominent Masks are facial and occipital thermoplastic masks which are used as part of the DSPS-Prominent system to facilitate accurate positioning and immobilization of the head, neck and shoulder region of the patient. DSPS-Prominent™ Baseplate, MR: The DSPS-Prominent baseplate, MR is an MR Safe baseplate which supports the positioning and immobilization of the patient within DSPS-Prominent occipital and facial masks. The device features a cantilevered frame on the cranial side which facilitates the use of both facial and occipital head, neck and shoulder masks. The device is fixed to the couch using couch strips. CouchStrip: CouchStrips are bars which connect the patient positioning device onto the treatment table at indexed positions. The DSPS-Prominent CouchStrip is MR Safe.
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    K Number
    K213439
    Device Name
    FlexBoardTM, EagleBoardTM, BreastBoard SXTM
    Manufacturer
    MacroMedics BV
    Date Cleared
    2022-06-24

    (242 days)

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

    MacroMedics BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FlexBoard™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) imaging systems. The EagleBoard™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems. The BreastBoard SX™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, proton, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) imaging systems.
    Device Description
    The FlexBoard™ base is a lightweight baseplate with a locking system specially designed to host multiple types of breast treatment modules, in order to facilitate the positioning of the patient for breast and chest treatments. Multiple variants of FlexBoard™ breast treatment modules are available. To enable enhanced treatment possibilities, the 122930 EagleBoard™-2 Base device can be used with the 172120 FlexBoard™ BTM-EX breast module as part of the FlexBoard™ setup. The EagleBoard™ devices consist of baseplates with a tapered design, and accessories, such as hand grips, which can be used together to support the positioning of the patient for breast and chest treatments. The 122930 EagleBoard™-2 Base device can be utilized both as part of a FlexBoard™ setup, or individually on the treatment table. The 122950 EagleBoard™-2 Base, MR and 122850 EagleBoard™ MR devices are intended to be utilized individually on the treatment table. The BreastBoard SX™ is a lightweight baseplate designed to facilitate the positioning of patients for breast and chest treatments. The BreastBoard SX™ is adjustable and can be secured at various tilt positions. It features an adjustable bottom-stop, arm support possibilities for positioning the patient's arms above their head, place for a head rest, and fixation points for thermoplastic masks.
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    K Number
    K212909
    Device Name
    VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips
    Manufacturer
    MacroMedics BV
    Date Cleared
    2022-05-11

    (240 days)

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

    MacroMedics BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
    Device Description
    The VacuumCushions (Vacuum Cushions) are cushions which are formed around the patient to create a rigid impression of the patient's anatomy in order to facilitate reproducible positioning. The impression is created through drawing the air out of the cushion whilst the patient is in the desired position. The FeetSupports facilitate the positioning of the patient's feet. They are available in fixed and rotatable variants and can be fixed to various baseplates and couchtops. The LEPS enables a patient's lower extremities to be positioned, using a Kneesupport, FeetSupport and, as desired, a LiftBlock. Shoulder Retractors can also be used to support the retraction of the patient's shoulders. The base of the LEPS is the LEPS baseplate. The LEPS Short baseplate enables the patient's feet to be positioned using a FeetSupport. The LEPS baseplates can be positioned on the couch treatment table using couch strips. CouchStrips are bars which connect the patient positioning device onto the treatment table at indexed positions. Depending on the indexing system of the treatment table, its width, the preference in transverse adjustability and required MR safety, different types and indexing styles are available. VacuumCushion Positioning Strips (VCPS) are CouchStrips which are placed onto other CouchStrips in order to secure a VacuumCushion in place.
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    K Number
    K142420
    Device Name
    Patient Positioning Devices
    Manufacturer
    MACROMEDICS BV
    Date Cleared
    2015-03-27

    (211 days)

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

    MACROMEDICS BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
    Device Description
    Baseplates and headsupports which are designed to position the head and neck and on which thermoplastic masks can be attached to fix the head and neck of the patient. Baseplates can be positioned on the couch using CouchStrips. The ExaFix-IMRT baseplates are attached onto the couches and extent the head of the patient from the couch at the cranial side. Various accessories offered for specific patient head and neck set-ups. The different headsupports are designed for different head positions. Different blocks are available for lifting the head, wedges and ExaTilt to incline the head. For the Exafix-5 baseplate an acrylic alternative (Exafix-5a) is available for identical head- and neck positioning in the MR environment. For the IMRT baseplates a glassfiber alternative (Exafix IMRT baseplate MR) is available for identical head- and neck positioning in MR environment. The MR safe devices have a 3Pin slot on the bottomside and are compatible with the glassfiber 3Pin CouchStrip. The MR unsafe devices are not compatible with the 3Pin MR safe CouchStrip, which prevents the use in the wrong environment. The BreastBoard LX and ThoraxSupports are devices which position the breast and lung area of a patient. The arms are placed above the head and a headsupport can be placed into the baseplate. The backsupport of the BreastBoard LX can be tilted, to tilt the upperpart of the patient´s body for other treatment possibilities. The ThoraxSupport does not have this tilting possibility. Various accessories are provided for positioning of the arms or the thorax. For the ThoraxSupport a glassfiber MR alternative (Thoraxsupport MR) is available for identical lung and thorax positioning in MR environment. The MR safe device has a 3Pin slot on the bottomside and is compatible with the glassfiber 3Pin CouchStrip. The MR unsafe devices are not compatible with the 3Pin MR safe CouchStrip, which prevents the use in the wrong environment. Baseplates which are designed to position the pelvic or (lower) extremities of a patient. The Pelvic Prone Board positions the patient in prone position with the arms in cranial direction, belly is placed in an aperture. The shape of the pelvic prone board moves the small bowel and reduces the irradiated small bowel volume while treating the lower abdomen. The LEPS position the legs on a KneeSupport which can be tilted and the feet are positioned in a FeetSupport. Both baseplates can be positioned on the couch using fixation rails. For the Pelvic Prone Board a glassfiber MR alternative (Pelvic Prone Board MR) is available for identical positioning in MR environment. The LEPS is a MR safe device. The MR safe devices have 3Pin slots on the bottomside and are compatible with the glassfiber 3Pin CouchStrip. The MR unsafe device is not compatible with the 3Pin MR safe CouchStrip, which prevents the use in the wrong environment. The SBRT systems (Stereotactic Body Radiation Therapy Systems) are devices which can position various bodyparts of the patient. The MacroMedics SBRT systems are carbon fiber baseplates over which various plastic bridges can be placed with attached accessories to position the patient's body. The SBRT OmniBoard does have an inclination possibility of the upper body. The accessories are identical, but the baseboards are different, each baseboard has slightly different features for customer preferences. The patient set-up is similar on all boards, supine position with the arms mainly positioned above the patient's head. Bottom, knees and feet positioned in indexed positions. Vacuumcushions are used for positioning by moulding the cushion around the patients and then take the air out with a vacuumpump. The contrashape of the patient stays in the cushion during the treatment. CouchStrips are strips which connect the patient positioning device onto the couch at indexed positions. Depending on the indexing system of the couch, width of the couch, preference in transverse adjustability and required MR safety different types are available. The SBRT carbon fiber baseplates are MR unsafe and have a 2Pin CouchStrip slot. They are not compatible with the 3Pin MR CouchStrip, which prevents the use in the wrong environment. The CouchStrips for MR are made out of MR safe materials and have 3pins. MR unsafe devices have a 2Pin CouchStrip slot on the bottomside and are not compatible with this 3Pin MR CouchStrip. The Vacuumcushions are MR safe. MacroMedics thermoplastic masks are developed in order to position the individual patient. The thermoplastic masks are placed in a waterbath of about 70 degrees where they become flexible. After drying and cooling, they make a perfect contramould of the bodypart which needs to be positioned. Plastic profiles attach the mask onto the baseplate. Masks and profiles are available in many different shapes, in order to fit on different baseplates and bodyparts. DSPS offers a possibility to create a thermoplastic mask for both occipital- and facial areas for extra accurate positioning. Both masks are attached onto the DSPS cradle, and the DSPS cradle is attached onto the baseplate. MacroMedics thermoplastic masks with plastic profiles are MR safe.
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