Duns Number:349363346
Device Description: The VivoSight Dx is indicated for use in the two-dimensional, cross-sectional, real-time i The VivoSight Dx is indicated for use in the two-dimensional, cross-sectional, real-time imaging of external tissues of the human body.This indicated use allows imaging of tissue microstructure including skin, and enables detection and display of regions within the scanned area that are in motion (Dynamic OCT) to aid trained and competent clinicians in their assessment of a patient's clinical conditions.
Catalog Number
-
Brand Name
VivoSight
Version/Model Number
VivoSight Dx
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K153283
Product Code
NQQ
Product Code Name
System, Imaging, Optical Coherence Tomography (Oct)
Public Device Record Key
4706958b-a7c7-4eaa-bd4b-3e4d63a11c01
Public Version Date
November 06, 2020
Public Version Number
4
DI Record Publish Date
November 14, 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. | 2 |