Duns Number:333707003
Device Description: Radiological Visualization Software for Diagnosis and Dental Treatment Planning
Catalog Number
6622463
Brand Name
SICAT Endo
Version/Model Number
6622463
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 02, 2021
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180262
Product Code
LLZ
Product Code Name
System, Image Processing, Radiological
Public Device Record Key
c4e38782-fbbd-4adb-9a91-2548190695e3
Public Version Date
July 05, 2021
Public Version Number
5
DI Record Publish Date
April 09, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |
| U | Unclassified | 1 |