Duns Number:949114925
Device Description: The Phoenix ICON retinal imaging system is a wide-field, handheld, high resolution, real t The Phoenix ICON retinal imaging system is a wide-field, handheld, high resolution, real time retinal imaging device. It is intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye.
Catalog Number
-
Brand Name
Phoenix ICON Cart System
Version/Model Number
PCI 40-1000
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
K170527
Product Code
HKI
Product Code Name
Camera, Ophthalmic, Ac-Powered
Public Device Record Key
a438073a-b7bd-4f0a-b8f0-cbdf619eea16
Public Version Date
December 08, 2021
Public Version Number
1
DI Record Publish Date
November 30, 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. | 5 |