Duns Number:077509759
Device Description: Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, 2 monitors Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, 2 monitors (one with touch screen) and keyboard/mouse.
Catalog Number
-
Brand Name
Gentuity HF-OCT Imaging System
Version/Model Number
Gentuity Imaging System G10-01 K192922
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"
-
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
K192922
Product Code
NQQ
Product Code Name
System, Imaging, Optical Coherence Tomography (Oct)
Public Device Record Key
3b234111-fd59-4d4f-a982-61ef523303ef
Public Version Date
June 30, 2021
Public Version Number
1
DI Record Publish Date
June 22, 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. | 3 |