Duns Number:081155097
Device Description: The IMAGEnet 6 ver. 2.2.1 is a software program that is intended for use in the collection The IMAGEnet 6 ver. 2.2.1 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.
Catalog Number
-
Brand Name
IMAGEnet 6
Version/Model Number
2.2.1
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
-
Product Code
HKI
Product Code Name
Camera, Ophthalmic, Ac-Powered
Public Device Record Key
63a369a1-7995-4155-ba22-93ac6cbdbf7c
Public Version Date
September 27, 2019
Public Version Number
1
DI Record Publish Date
September 19, 2019
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. | 25 |