Duns Number:433051802
Device Description: X-MIND trium PAN CBCT version including one CEPH sensor,with control panel on the right s X-MIND trium PAN CBCT version including one CEPH sensor,with control panel on the right side including one removable ceph sensor configurated for installation of ceph arm on the left
Catalog Number
W0900005
Brand Name
X-MIND trium
Version/Model Number
XMT PAN 3D R CEPH READY L
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 15, 2016
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
K160166
Product Code
MUH
Product Code Name
System,X-Ray,Extraoral Source,Digital
Public Device Record Key
bf18f6f3-1f59-47cf-84f7-3b93a4c4d56b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 15, 2016
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. | 63 |