Duns Number:362747011
Device Description: The CLARUS is an active, non-contact, software controlled, high resolution imaging device The CLARUS is an active, non-contact, software controlled, high resolution imaging device for in-vivo imaging of the human eye. The CLARUS ophthalmic camera is indicated to capture, display, annotate and store images to aid in the diagnosis and monitoring of diseases and disorders occurring in the retina, ocular surface and visible adnexa. It provides true color and autofluorescence imaging modes for stereo, widefield, ultra-widefield, and montage fields of view. The CLARUS Review Software can be installed on a separate review station (PC or laptop) for data review and analysis.
Catalog Number
-
Brand Name
CLARUS
Version/Model Number
CLARUS Review Software
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
K181444
Product Code
QER
Product Code Name
Camera, Ophthalmic, Slit-Scanning
Public Device Record Key
b8bbe285-1f34-4414-87bf-7a851f294f41
Public Version Date
March 08, 2019
Public Version Number
3
DI Record Publish Date
September 25, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |