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

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Disponível em:

Leica Microsystems Pty Ltd

Classe:

Class IIa

Fabricado por:

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

Área terapêutica:

58850 - Spectral-domain optical coherence tomography system

Indicações terapêuticas:

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 de autorização:

A

Data de autorização:

2021-07-07