ARTG 370708Spectral-domain optical coherence tomography system - Spectral-domain optical coherence tomography system
ARTG ID: 370708 · Leica Microsystems Pty Ltd · Leica Microsystems NC Inc · Class IIa · Started July 07, 2021
Good Name: Leica Microsystems Pty Ltd - Spectral-domain optical coherence tomography system - Spectral-domain optical coherence tomography system
- Risk Class
- Class IIa
- Product Type
- Medical device system
- ARTG Category
- General
- ARTG ID
- 370708
- Start Date
- July 07, 2021
- Effective Date
- July 07, 2021
- Country
- United States of America
- Address
- 4222 Emperor Blvd Suite 390, Durham, NC, 27703
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.
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 registered under ARTG number 370708 and 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.
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