Spectralis HRA+OCT - Heidelberg Retina Angiograph + Optical Coherence Tomograph - Spectral-domain optical coherence tomography system

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Avaliku hindamisaruande Avaliku hindamisaruande (PAR)
09-11-2017

Saadav alates:

Heidelberg Engineering Pty Ltd

Klass:

Class IIa

Valmistatud:

Heidelberg Engineering GmbH Max-Jarecki-Strasse 8, Heidelberg, 69115 Germany

Terapeutiline ala:

58850 - Spectral-domain optical coherence tomography system

Näidustused:

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.

Volitamisolek:

A

Loa andmise kuupäev:

2014-04-17

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