Australia - engelsk - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 40898 - patient positioning device, diagnostic imaging/radiotherapy, head/neck - intended to support the delivery of radiation to a defined target volumes according to a pre-existing treatment plan; intended to be used for repeated non invasive fixation of patients head; intended to be attached to the headring or mask system.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 35361 - stereotactic headframe, diagnostic imaging - the headring is intended to be used for fixation of patients head. it provides a rigid basis for mounting ct or x-ray compatible localizers for scan procedures and target positioners for radiotherapy/radiosurgery treatments.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 12440 - marker, - the device is intended as a rigid solution for fixation of the reference star to the patient head.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 40805 - marker, image identification, manual - a calibration marker used for orthopaedic preoperative planning.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 42895 - robotic surgical system software, navigation - indications for use are the viewing, presentation and documentation of medical imaging, including different modules for image processing, image fusion, altas assisted visualization and segmentation, intraoperative functional planning where the output can be used e.g., with stereostatic image guided surgery or other devices for further processing and visualization.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 40897 - patient positioning device, diagnostic imaging/radiotherapy, indexed immobilization - this device is used for the immobilization of the patient's cranial area, and head and neck area in a ct- and linear accelerator environment.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 62380 - surgical instrument assist arm system, power-adjusted - the device is intended to be an intraoperative image guide localization system to support the surgeon to achieve pre-planned trajectories with surgical instruments. it is indicated for use in the treatment of diseases where the placement of spinal screws is indicated and for the diagnosis of diseases where the biopsy of intracranial lesions is indicated.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 60723 - medical image management system - for the integration of devices and for the distribution of video signals and multimedia content. it is intended to be used for communication between compatible devices. it provides centralized access for managing video data, medical images and patient data.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 62380 - surgical instrument assist arm system, power-adjusted - the positioning arm is indicated to assist in maintaining spatial positioning of (third-party) instruments during neurosurgical procedures or for the placement of spinal screws. it may be used in either open or minimally invasive or percutaneous procedures.; the positioning arm provides an interface at its distal end. to this interface adapters for the fixation of the surgical instruments can be attached. these adapters and instruments can be third-party solutions if they fulfill the defined interface requirements. the instruments used in the neurosurgical or spinal setup have to be compatible to a surgical navigation. the sterility must be ensured via the attached adapter with a sterile drape.

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 32390 - drill bit, surgical - the device is intended to be used to create cylindrical cavities in bone tissue for subsequent implant placement.