Spectral-domain optical coherence tomography system - Spectral-domain optical coherence tomography system

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
19-07-2021

Dostopno od:

Leica Microsystems Pty Ltd

Razred:

Class IIa

Izdeluje:

Leica Microsystems NC Inc 4222 Emperor Blvd Suite 390, Durham, NC, 27703 United States Of America

Terapevtsko območje:

58850 - Spectral-domain optical coherence tomography system

Terapevtske indikacije:

The Ophthalmic Imaging system is intended to acquire, process, display and save depth-resolved images of ocular tissue microstructure using Spectral Domain Optical Coherence Tomography (SDOCT). The Ophthalmic Imaging system is indicated for use as an aid in the visualization of physiologic and pathologic conditions of the eye through non-contact optical imaging. It is indicated for use on patient populations from premature and neonatal infants to adult. The system is indicated for use in supine imaging, mounted to a surgical microscope, with cooperative patients or patients under anesthesia.

Status dovoljenje:

A

Datum dovoljenje:

2021-07-07

Opozorila o iskanju, povezana s tem izdelkom