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

brainlab australia pty ltd - 43390 - sterile fluted surgical drill - drill bit cranial is intended to be used to create cylindrical cavities in the skull in order to gain access to predefined regions of the brain. it is an accessory to compatible brainlab image guided surgery applications.

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

brainlab australia pty ltd - 47863 - orthopaedic implant/instrument depth limiter - drill depth stop is intended to limit the maximum drill depth of a surgical drill bit. it is an accessory to compatible brainlab image guided surgery applications.

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

brainlab australia pty ltd - 40887 - radiation therapy treatment planning system, application program software - for use in stereotactic, conformal, computer planned, linac based radiation treatment of cranial, head and neck, and extracranial lesions.

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

brainlab australia pty ltd - 40887 - radiation therapy treatment planning system, application program software - this device is intended to position patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

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

brainlab australia pty ltd - 42275 - collimator, radionuclide, stereotactic radiosurgery - intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation

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

brainlab australia pty ltd - 40807 - marker, lesion localization, external - reflective marker spheres are used in conjunction with computer assisted surgery (cas) or radiotherapy intended to create a reference between the patient?s anatomy and the image data on a dedicated navigation or patient positioning system.

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

brainlab australia pty ltd - 18054 - accelerator system, stereotactic radiosurgery - to be used as a dedicated system to plan, to perform and to document radiosurgery or stereotactic radiotherapy for lesions (eg. arteriovenous malformations), tumors, head and neck targets, functional disorders and extracranial indications.

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

brainlab australia pty ltd - 38723 - robot, surgical, navigation unit - intended to be an intra-operative image guided localization system to enable precision surgery. indicated for medical conditions where the use of stereotactic surgery may be appropriate.

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

brainlab australia pty ltd - 35361 - stereotactic headframe, diagnostic imaging - intended to be used to fixate the patients head in a rigid position related to the headring.

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

brainlab australia pty ltd - 31670 - stylet, catheter - the disposable stylet is a pre-calibrated guiding stylet for free hand and navigaged placement of catheters/shunts in neurosurgery. the package contains only the stylet.