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The VivaScope® System is intended to acquire, store, retrieve, display and transfer in vivo images of tissue, including blood, collagen and pigment, in exposed unstained epithelium and the supporting stroma for review by physicians to assist in forming a clinical judgment.

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. The VivaScope System produces horizontal sections of the skin using safe, low power infrared laser light at nominal wavelength of 830 nm (CDRH laser Class I). Horizontal sections make it straightforward to view the various layers of the skin in sequence, from the outer surface of the stratum comeum, through the granular, spinous and basal layers, to the level of the superficial reticular dermis. The VivaScope® System produces high resolution images of the skin using confocal laser scanning microscopy. The key feature of confocal microscopy is the ability to produce in-focus images of thick specimens called "optical sectioning". The system is able to accomplish this by having the point source laser light, the illuminated spot in the sample, and the pinhole all lie in optically conjugate [ocal planes. The size of the pinhole (located in front of the photodiode) is matched to the size of the illuminated spot to reject out of focus light allowing for imaging of thin optical sections. The VivaScope® System can image, display, store, retrieve, import and export in vivo confocal and macroscopic color images using the VivaScan operating software and supportin hardware. Images are saved and stored using standard lossless image compression algorithms. Images are communicated to other devices using DICOM standard functionality that is incorporated into the VivaScan® operating software. The VivaScope® System is comprised of four (4) major functional components: an imager, a display, a PC and a cart. A VivaScope® System will have either a VivaScope® arm mounted imaging head or a VivaScope® handheld imaging head, or both, and optionally, a VivaCam® full color macroscopic imaging head.