Spectral-domain optical coherence tomography system - Spectral-domain optical coherence tomography system
Access comprehensive regulatory information for Spectral-domain optical coherence tomography system - Spectral-domain optical coherence tomography system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Leica Microsystems Pty Ltd, manufactured by Leica Microsystems NC Inc in United States of America. The device registration started on July 07, 2021.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
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.