VivaScope System

GUDID 00860292000306

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.

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• Primary Device ID: 00860292000306
• NIH Device Record Key: 09a34b16-ef0c-4b0f-ab00-ce177f419e12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VivaScope System
• Version Model Number: 1500, 3000, or both
• Company DUNS: 795857648
• Company Name: Caliber Imaging & Diagnostics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5857582816
• Email: cmalessi@caliberid.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860292000306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080788

FDA Product Code

• FSS: Light, Surgical, Floor Standing
• PSN: Light Based Imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-25
• Device Publish Date: 2016-08-22

On-Brand Devices [VivaScope System]

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