Caliber Imaging & Diagnostics, Inc.

Address:50 Methodist Hill Dr Ste 1000,ROCHESTER,NY,14623,US

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Light, Surgical, Floor Standing (FSS) (1)

Premarket Exempt

Clear

VivaScope System - 00860292000306 Catalog Number :

Device Description : The VivaScope® System is a reflectance confocal microscope, full color macroscop 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 thetissue, through the unstained epithelium and into the superficial supporting stroma. It providesnon-invasive in vivo images of the epithelium and supporting stroma. The VivaScope® Systemdoes NOT provide automated analysis or diagnosis of the images it produces. It is capable ofimaging cells in the epidermis of skin and the fibrous tissue (primarily collagen and fibrin) in thedermis. In addition, it is possible to visualize circulation of blood cells (including botherythrocytes and leukocytes) in capillaries and other small vessels.

Device Class : 2

Duns Number: 795857648

Premarket Exempt : No

Product Code : FSS

Prescription Use : No

Device Count : 1

Previous 1 Next