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

heidelberg engineering pty ltd - 36225 - microscope, laser optical scanning - the heidelberg retina tomograph is a confocal scanning laser system for the acquisition and analysis of three-dimensional images of the posterior and anterior segment of the eye. moduleas include glaucoma, retina and corneal. corneal modules converts system to a confocal corneal microscope.

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

heidelberg engineering pty ltd - 58850 - spectral-domain optical coherence tomography system - the spectralis is a non-contact ophthalmic diagnostic imaging device for: viewing the posterior segment of the eye, including two- and three-dimensional imaging; cross-sectional imaging (spectralis hra+oct and spectralis oct); fundus imaging; fluorescence imaging (fluorescein angiography, indocyanine greenangiography; spectralis hra+oct, spectralis hra); autofluorescence imaging (spectralis hra+oct, spectralis hra and spectralis oct with bluepeak); performing measurements of ocular anatomy and ocular lesions. it is indicated as an aid in the detection and management of various ocular diseases, including age-related macular degeneration; macular oedema; diabetic retinopathy; retinal and choroidal vascular diseases; glaucoma and for viewing geographic atrophy as well as changes in the eye that result from neurodegenerative diseases. the spectralis oct angiography module is indicated as an aid in the visualization of vascular structures of the retina and choroid. the spectralis hra+oct and spectralis oct include reference databases for measurements of retinal layer and optic nerve head anatomy, which are used to quantitatively compare measurements in the human retina and optic nerve head to values found in normal subjects.

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

heidelberg engineering pty ltd - 58860 - multi-purpose digital medical camera external ophthalmoscopic lens - anterior segment module is an accessory to the spectralis and is indicated for imaging the anterior segment of the eye, including sclera, cornea, anterior chamber angles, and iris, and to perform measurements of the anterior anatomic structures with necessary software.

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

heidelberg engineering pty ltd - 58860 - multi-purpose digital medical camera external ophthalmoscopic lens - the ultra widefield angiography module is an objective lens to acquire a 102' image of the retina. this is an accessory to the spectralis.

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

heidelberg engineering pty ltd - 58860 - multi-purpose digital medical camera external ophthalmoscopic lens - this is to acquire a widefield (55') image of the retina

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

heidelberg engineering pty ltd - 58860 - multi-purpose digital medical camera external ophthalmoscopic lens - the high magnification module is an objective lens used to acquire images of the retina with using a higher magnification for more detail and clarity. this is an accessory to the spectralis.

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

heidelberg engineering pty ltd - 45729 - anterior eye segment analysis system - the anterion is a non-contact ophthalmic imaging and analysis device for the eye. it is intended for the visualization and measurements of the anterior segment and the measurement of; the axial length.; the analysis covers:; - cornea; - shape and thickness; - anterior segment; - anterior chamber width, depth, volume, and angle parameters; - lens thickness; - axial length; - pupil diameter; - white-to-white distance; the anterion also performs calculations to assist users in determining the power of the intraocular lens for implantation.

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

heidelberg engineering pty ltd -

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

heidelberg engineering pty ltd - 40943 - workstation, picture archiving and communication system - ashvins is a modular software solution and is used for viewing, reporting, processing, storing, printing, and archiving, as well as for the exchange and distribution or web-based distribution of digital, multimodal medical images, including mammographic images and bio-signals, as well as findings and demographic information. ashvins also collects, manages, and distributes patient-related and device-related information. ashvins offers advanced image processing functions such as multiplanar reconstruction, 3d reconstruction and measurement functions. for primary image diagnosis in mammography only uncompressed or non-lossy compressed images and only pre-processed dicom ?for presentation? images must be used. existing regulatory or legal requirements regarding hardware, such as diagnostic monitors, that are applicable for diagnosing in respective imaging specialties must be observed. ashvins is designed to be used by trained professionals, including but not limited to physicians, radiologists, ophthalmologists, nurses, medical technicians, and assistants

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

heidelberg engineering pty ltd -