Duns Number:689229516
Device Description: Dental Computed Tomography X-ray System intended to produce panoramic, cephalometric or c Dental Computed Tomography X-ray System intended to produce panoramic, cephalometric or cross-sectional images of the oral anatomy by computer reconstruction of x-ray Image data (Xmaru3104CF)
Catalog Number
-
Brand Name
PaX-i3D Green Premium / Green 21
Version/Model Number
PCT-90LH
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
K160882
Product Code
OAS
Product Code Name
X-Ray, Tomography, Computed, Dental
Public Device Record Key
54f4ca17-faa9-43bf-add3-8d7371261008
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 30, 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. | 76 |