Duns Number:200584196
Device Description: CARA is an innovative software program that uses enhanced digital images to support and id CARA is an innovative software program that uses enhanced digital images to support and identify the early detection of vision loss and more specifically diabetic retinopathy. CARA is a teleophthalmology platform which includes advanced retinal imaging technology and clinical grading services by eye care professionals.
Catalog Number
-
Brand Name
CARA
Version/Model Number
Version 4
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NFJ
Product Code Name
System, Image Management, Ophthalmic
Public Device Record Key
a494cafe-e218-4ae6-bb09-dfd572b78495
Public Version Date
September 24, 2018
Public Version Number
2
DI Record Publish Date
June 04, 2018
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 |