Michelson Diagnostics VivoSight OCT Scanner Receives FDA 510(k) Clearance
ORPINGTON, United Kingdom, Jan. 12, 2010 (GLOBE NEWSWIRE) -- Michelson Diagnostics Ltd, the London, UK based developer and manufacturer of Optical Coherence Tomography (OCT) products, announced today that the US Food & Drug Administration (FDA) has awarded it 510(k) clearance for its VivoSight(TM) OCT scanning product.
For clinical use, FDA 510(k) K093520 applies: "VivoSight(TM) 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."
VivoSight(TM) is the first Fourier-Domain OCT scanner to receive FDA 510(k) clearance, outside of the field of ophthalmology ...
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