Duns Number:071991843
Device Description: OpenSight is the combination of augmented reality glasses and Novarad's medical imaging so OpenSight is the combination of augmented reality glasses and Novarad's medical imaging software to create three-dimensional holograms of scanned images from different modalities including CR, DX, CT, MR, and PT.
Catalog Number
-
Brand Name
OpenSight
Version/Model Number
OpenSight 1.8804
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
-
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
K172418
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
bb2215af-a5e7-42f0-b2e8-761b7b8ddb4e
Public Version Date
July 19, 2021
Public Version Number
1
DI Record Publish Date
July 09, 2021
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. | 41 |