VivaScope System

Basic Information

• Brand Name: VivaScope System
• Primary DI: 00860292000306
• Version / Model: 1500, 3000, or both
• Company Name: Caliber Imaging & Diagnostics, Inc.
• Labeler DUNS: 795857648
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-22
• Public Version: 6
• Public Version Date: 2025-02-05
• Public Version Status: Update
• Public Device Record Key: 09a34b16-ef0c-4b0f-ab00-ce177f419e12

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PSN	Light Based Imaging	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36225	Scanning laser optical microscope	A microscope designed to obtain high-magnification cross-sectional [three-dimensional (3-D)] images by scanning the sample with the focused point of laser light, restricting the illumination to a tiny, targeted section of the specimen while eliminating out-of-focus light (confocal microscopy). The image data is detected, amplified, and usually digitized and displayed on a high resolution (typically 1024 x 1024 pixel) monitor. The data can be stored, e.g., in a computer. This microscope can be mounted on conventional or specially designed light microscopes, e.g., upright or inverted stage, and is mostly used for cell and molecular biology examinations, e.g., cells, cell cultures or tissue.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860292000306	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K080788	000
K180162	000