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VivaScope System

Caliber Imaging & Diagnostics, Inc. · Model 1500, 3000, or both · UDI-DI 00860292000306

510(k) clearances

Adverse events

Recalls

Facilities

Description

The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager, and software that captures images of in vivo tissue specimens from the exposed surface of the tissue, through the unstained epithelium and into the superficial supporting stroma. It provides non-invasive in vivo images of the epithelium and supporting stroma. The VivaScope® System does NOT provide automated analysis or diagnosis of the images it produces. It is capable of imaging cells in the epidermis of skin and the fibrous tissue (primarily collagen and fibrin) in the dermis. In addition, it is possible to visualize circulation of blood cells (including both erythrocytes and leukocytes) in capillaries and other small vessels.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.