Duns Number:690635461
Device Description: The SYSTEM CHART SC-1600 is a chart presenting device that displays the charts on an LCD. The SYSTEM CHART SC-1600 is a chart presenting device that displays the charts on an LCD. The charts are controlled by an optional remote control or the control box of the NIDEK refractor*1. In contrast to a chart presenting device which projects the charts from film, the SC-1600 displays the digitally stored chart shapes on the LCD. This makes the following possible.
Catalog Number
-
Brand Name
SYSTEM CHART
Version/Model Number
SC-1600
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
HOX
Product Code Name
Chart, Visual Acuity
Public Device Record Key
b74c6f96-c273-454f-ad07-5e94629a0df9
Public Version Date
July 22, 2019
Public Version Number
2
DI Record Publish Date
April 20, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 73 |
| 3 | A medical device with high risk that requires premarket approval | 5 |