VivaScope System

Primary DI
00860292000306
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
2016-08-22
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
FSSLight, Surgical, Floor Standing
PSNLight Based Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSSLight, Surgical, Floor StandingGeneral, Plastic Surgery2
PSNLight Based ImagingGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080788000
K180162000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080788000VIVASCOPE SYSTEM, MODEL 1500, 3000Lucid, Inc.2008-09-17PSN
K180162000VivaScope SystemCaliber Imaging & Diagnostics, Inc.2018-05-03PSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860292000306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860292000306008602920003068602920003060860292000306

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
5857582816cmalessi@caliberid.com
+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
08602920003066VivaScope System1500, 3000, or both2023-02-16

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
00855373008036NICO Myriad-LXSUNOPTIC TECHNOLOGIES LLCFSS2025-06-03
00855373008043NICO Corporation SUNOPTIC TECHNOLOGIES LLCFSS2025-06-03
M678NN70640NICO Myriad-LXSUNOPTIC TECHNOLOGIES LLCFSS2025-03-27
M678NN90100NICOSUNOPTIC TECHNOLOGIES LLCFSS2025-03-27
10686864056819Medicom SafeMaskAMD Medicom IncFSS2025-01-23
20686864056816Medicom SafeMaskAMD Medicom IncFSS2025-01-23
03700712412029Maquet RoliteMAQUET SASFSS2024-11-07
04250613849282DM MS Sim.LED ExL DES.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849305MS Sim.LED OpL wSBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849329MS Sim.LED OpL wDBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849367MS Sim.LED OpL USS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
04250613849404DM MS Sim.LED ExL wSBS.I.M.E.O.N. Medical GmbH & Co. KGFSS2024-09-16
03700712432508Maquet RoliteMAQUET SASFSS2024-06-20
03700712432522Maquet RoliteMAQUET SASFSS2024-06-20
03700712432515Maquet RoliteMAQUET SASFSS2024-02-02
14026704741837PILLINGTELEFLEX INCORPORATEDFSS2024-01-16
24026704741834PILLINGTELEFLEX INCORPORATEDFSS2024-01-16
03700712432539Maquet RoliteMAQUET SASFSS2023-12-15
03700712422745Maquet RoliteMAQUET SASFSS2023-09-19
03700712422752Maquet RoliteMAQUET SASFSS2023-09-19
03700712422769Maquet RoliteMAQUET SASFSS2023-09-19
03700712422776Maquet RoliteMAQUET SASFSS2023-09-19
03700712422783Maquet RoliteMAQUET SASFSS2023-09-19
03700712422790Maquet RoliteMAQUET SASFSS2023-09-19
03700712422806Maquet RoliteMAQUET SASFSS2023-09-19
03700712422813Maquet RoliteMAQUET SASFSS2023-09-19
03700712422820Maquet RoliteMAQUET SASFSS2023-09-19
03700712422837Maquet RoliteMAQUET SASFSS2023-09-19