Austrália - inglês - Department of Health (Therapeutic Goods Administration)

smith & nephew pty ltd - 38723 - robot, surgical, navigation unit - the brainlab navigation system is used to enable image guided orthopaedic surgery by optimising navigation with pre-op planning and surgical visualisation.

Cingapura - inglês - HSA (Health Sciences Authority)

johnson & johnson pte ltd - radiology / imaging - the kick 2d navigation system is intended to be a pre- and intraoperative image guided localization system to enable minimally invasive surgery. it links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient’s pre- or intraoperative image data being processed by a brainlab navigation workstation. the system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a bone structure like tubular bones, pelvic, calcaneus and talus, scapula, or vertebra, can be identified relative to a ct, fluoroscopic, x-ray or mr based model of the anatomy.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 40887 - radiation therapy treatment planning system, application program software - device is a software platform to integrate the different brainlab systems into one application, to allow remote treatment planning and to organise the workflow within cooperating departments. it organizes the treatment planning workflow within a radiotherapy department to reflect department specific steps. it organizes treatment tasks for hospital personnel and provides a central repository for searching and commenting on patients.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 38723 - robot, surgical, navigation unit - intended to enable control of a brainlab computer device within the sterile field.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 38723 - robot, surgical, navigation unit - the brainlab navigation system is used to enable image guided surgery by optimising navigation with pre-op planning and surgical visualisation.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 45018 - non-implantable needle guide, single-use - a removable needle insert used with a separately supplied pedicle access instrument (an instrument component of the brainlab spine & trauma igs). the removable needle insert is supplied non-sterile. prior to a surgical procedure it is sterilised by the hospital along with a reusable pedicle access instrument. when inserted into the pedical access instrument it is intended for manual-calibrated use in combination with brainlab spine & trauma igs software applications and placement of k-wires into thoraco-lumbar pedicles (as an instrument positioning device). the needle insert is intended for single-use.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 38723 - robot, surgical, navigation unit - microscope navigation is a module, that when used with a brainlab navigation system and compatible instrument accessories, is intended as image guided planning and navigation system to navigated surgery. it links an instrument and the view of the surgical field (e.g. video, view through surgical microscope) to a virtual computer image space on patient image data being processed by the computer. the system is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (ct, cta, x-ray, mr, mra and ultrasound) of the anatomy.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 13730 - sterilization container - these sterilization trays shall be used to support steam and plasma sterilization and storage of the brainlab instruments to be used for the respective (named) application.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 60724 - medical image management system application software - intended to be used as central patient data server by brainlab and 3rd party medical applications for patient data communication, storage and exchange based on the dicom standard. it also starts and manages other services (performers) upon availability of data.

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

brainlab australia pty ltd - 62783 - electromagnetic/optical surgical navigation device tracking system - the device enables a brainlab navigation system with compatible software to register image data intraoperatively.