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

brainlab australia pty ltd - 60363 - implantable electrical stimulation device management software - the device provides functionality for the processing, visualization and documentation of medical imaging and the simulation of neural activation evocated by neurological electrodes. it is intended to be used to aid the planning and simulation of these electrodes for stimulation. it is indicated to be used in the context of minimal invasive cranial neurological procedures where the placement and programming of electrodes to treat a neurological disorder is appropriate.

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

brainlab australia pty ltd - 62783 - electromagnetic/optical surgical navigation device tracking system - the device enables image guided surgery. it is a hardware device used for surgery. the hardware hosts one or more software applications. it incorporates a computer and display unit to facilitate the display, exchange, processing and interaction with data and tracking for imaged guided surgery purposes.

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

brainlab australia pty ltd - 12535 - medical equipment drape, single-use - the loop-x disposable sterile drape set is an accessory for the loop-x imaging device. the drape set creates a sterile barrier between the or field and the imaging device, allowing intraoperative 2d imaging of patients in a sterile environment. the loop-x disposable sterile drape set does not have clinical indications independently from the loop-x device.

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

brainlab australia pty ltd - 40885 - radionuclide system, therapeutic, stereotactic radiosurgery, application program software - the software uses digital bioimaging to support treatment planning it is intended to transfer dicom data to and from picture archiving and communication systems (pacs) and other storage media devices. it includes modules for viewing, image processing, fusion, segmentation and 3d visualization of medical image data for treatment procedures.

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

brainlab australia pty ltd - 60724 - medical image management system application software - the software displays medical images and data and includes functions for image review, image manipulation, basic measurements and 3d visualization. the device itself does not have clinical indications.

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

brainlab australia pty ltd - 40885 - radionuclide system, therapeutic, stereotactic radiosurgery, application program software - medical device software for image guided surgery and provides an image registration for intraoperatively acquired 3d fluoroscopic image reconstructions.

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

brainlab australia pty ltd - 62783 - electromagnetic/optical surgical navigation device tracking system - the device is a software enabling computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively. the software is part of a system intended to be used for intraoperative image-guided localization to enable open and minimally invasive surgery. 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, the pelvis, a long bone or vertebra can be identified relative to the acquired image (ct, mr, 3d fluoroscopic image reconstruction or 2d fluoroscopic image) and/or an image data based model of the anatomy.

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

brainlab australia pty ltd - 62783 - electromagnetic/optical surgical navigation device tracking system - the device enables active patient registration for image guided surgery and remote control of selected features within the software when used in combination with passive pointers and compatible igs and stereotactic software applications.

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

brainlab australia pty ltd - 62783 - electromagnetic/optical surgical navigation device tracking system - the devices are intended to support surgical instrument guidance during navigated surgical procedures

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

brainlab australia pty ltd - 62379 - endoscope/instrument holder, manual-adjusted - the device is intended to be used with a navigation system and with compatible software to enable image guided surgery .