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VivoSight Dx 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 Dx is a Multi-Beam Optical Coherence Tomography (OCT) system.

This document is a 510(k) clearance letter for the VivoSight Dx Topical OCT System. It does not contain information about specific acceptance criteria, device performance results, or details of a study proving the device meets acceptance criteria.

The letter confirms that the FDA has reviewed Michelson Diagnostics Ltd.'s premarket notification and determined that the VivoSight Dx device is substantially equivalent to legally marketed predicate devices. This determination is based on the provided "Indications for Use" and generally implies that the device performs as intended and is safe and effective when used as described, similar to comparable devices already on the market.

Therefore, I cannot provide the requested information from this document. The information you're asking for would typically be found in the 510(k) submission itself, where the manufacturer presents data and analysis to support their claims of substantial equivalence. This letter is simply the FDA's decision based on that submission.

To answer your questions, I would need access to the actual 510(k) submission document for K153283, specifically the sections detailing performance testing and clinical data.

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