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

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

Leica Microsystems Pty Ltd

Klass:

Class IIa

Tillverkad av:

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

Terapiområde:

58850 - Spectral-domain optical coherence tomography system

Terapeutiska indikationer:

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.

Bemyndigande status:

A

Tillstånd datum:

2021-07-07