For clinical use in the US FDA 510(k) K093520 applies:
- VivoSight is a Multi-Beam Optical Coherence Tomography (OCT) system indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body. - US Federal law restricts this device to sale by or on the order of a physician.
Summary specification:
Patented Multi-Beam OCT op ...
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