VivaScope System

GUDID 08602920003066

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.

Caliber Imaging & Diagnostics, Inc.

Scanning laser optical microscope
Primary Device ID08602920003066
NIH Device Record Key4ad6233d-602c-455a-89e6-13d312d849b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivaScope System
Version Model Number1500, 3000, or both
Company DUNS795857648
Company NameCaliber Imaging & Diagnostics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108602920003066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PSNLight Based Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-24
Device Publish Date2023-02-16

On-Brand Devices [VivaScope System]

00860292000306The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager, and
08602920003066The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager, and

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