Duns Number:117170604
Device Description: Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral Videa Caries Assist is a computer-assisted detection (CADe) device that analyzes intraoral radiographs to identify and localize carious lesions.Videa Caries Assist is indicated for the review of bitewing (BW) radiographs acquired from adult patients aged 22 years or older.
Catalog Number
-
Brand Name
Videa Caries Assist
Version/Model Number
VCA01B
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
K213795
Product Code
MYN
Product Code Name
Analyzer, Medical Image
Public Device Record Key
fc950bef-2d02-49c4-8e67-afd4cef302eb
Public Version Date
July 14, 2022
Public Version Number
1
DI Record Publish Date
July 06, 2022
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 |