Duns Number:035304046
Device Description: The iScreen Vision Screener 3000 is a vision screening tool intended to capture and record The iScreen Vision Screener 3000 is a vision screening tool intended to capture and record red reflex images which contain information on ocular status to aid in eye examination. The iScreen Vision Screener 3000 is intended for use solely for a pediatric population by trained professionals.
Catalog Number
-
Brand Name
iScreen Vision
Version/Model Number
iScreen Vision Screener 3000
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
K102651
Product Code
HKI
Product Code Name
Camera, Ophthalmic, Ac-Powered
Public Device Record Key
578c673b-8a53-4f09-9f11-06f794ee6dbf
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 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 |