Duns Number:812635448
Device Description: The BI IMAGE-X EVOLUTION® device is an extraoral x-ray generator that provides the radiati The BI IMAGE-X EVOLUTION® device is an extraoral x-ray generator that provides the radiation necessary for the formation of a radiographic image from which a radiographic diagnosis may be made.The BI IMAGE-X EVOLUTION® is an extraoral x-ray generator system designed to be used in combination with an intraoral image receptor for radiographic examinations (which assist in diagnosis of diseases of the teeth, jaw, and oral structure) by dental professionals.
Catalog Number
-
Brand Name
BI Image-X
Version/Model Number
Evolution
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160458
Product Code
EHD
Product Code Name
Unit, X-Ray, Extraoral With Timer
Public Device Record Key
7bdc26f9-44af-4a6d-9b5e-7f5c9f0667b0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 12, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |