VivaScope System

Primary DI
08602920003066
Brand
VivaScope System
Company
Caliber Imaging & Diagnostics, Inc.
Model
1500, 3000, or both
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 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.
Published
2023-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PSNLight Based Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSNLight Based ImagingGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180162000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180162000VivaScope SystemCaliber Imaging & Diagnostics, Inc.2018-05-03PSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08602920003066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08602920003066086029200030668602920003066

GMDN Terms#

Term, Definition table
TermDefinition
Scanning laser optical microscopeA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (585) 758-2826jradford@caliberid.com

Regulatory Flags#

DUNS number
795857648
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08602920003035VivaScope 250025002023-02-16
00860292000306VivaScope System1500, 3000, or both2016-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013961404DermoSight DermatoscopeDEEPX HEALTH, LLCPSN2025-06-19
00860013961411DermoSight SoftwareDEEPX HEALTH, LLCPSN2025-06-19
05415334036192DemetraBarco NVPSN2021-06-28
05415334001763DemetraBarco NVPSN2020-06-04
00628451918035MoleMateMedX Health CorpPSN2016-09-22
00628451918004MoleMateMedX Health CorpPSN2016-09-22
00628451918073SIMSYSMedX Health CorpPSN2016-09-22
00860292000306VivaScope SystemCaliber Imaging & Diagnostics, Inc.PSN2016-08-22