www.fdanews.com/articles/186826-caliber-imaging-diagnostics-gets-510k-clearance-for-vivascope
Caliber Imaging & Diagnostics Gets 510(k) Clearance for VIVASCOPE
May 15, 2018
Caliber Imaging & Diagnostics won 510(k) clearance from the FDA for modifications to its VIVASCOPE imaging system, a microscopy tool that allows dermatologists to non-invasively visualize cellular structures in the skin.
The recent modifications to the system include improved ergonomics and imaging capabilities.
The system uses a low-powered laser to provide high-resolution images of the epidermis in thin, optical slices. The optical sectioning can help physicians in their clinical judgments.