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 optics


• 2D & 3D image capture with hand-held probe


• 5 mm x 5 mm x 2 mm (w x l x d) image size


• < 7.5 µm lateral resolution


• < 10 µm vertical resolution (in tissue)


• Frame rate 6.5 fps (5 mm scan width)


• Up to 35 fps (0.25 mm scan width)


• TIFF & TIFF-stack image format