Duns Number:795857648
Device Description: The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager, 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.
Catalog Number
-
Brand Name
VivaScope System
Version/Model Number
1500, 3000, or both
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080788
Product Code
FSS
Product Code Name
Light, Surgical, Floor Standing
Public Device Record Key
09a34b16-ef0c-4b0f-ab00-ce177f419e12
Public Version Date
March 25, 2019
Public Version Number
4
DI Record Publish Date
August 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |