Duns Number:429341410
Device Description: Extraoral Xray system for digital Xrays imaging suitable for:- production of orthopanora Extraoral Xray system for digital Xrays imaging suitable for:- production of orthopanoramic images of the maxillofacial region, diagnostic examination of the dentition (teeth), arches and other structures of the oral cavity- produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, stmctures of the oral cavity and some cranial bones
Catalog Number
XGO3D16
Brand Name
NewTom
Version/Model Number
NewTom GO (3D)
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
K161900
Product Code
MUH
Product Code Name
System,X-Ray,Extraoral Source,Digital
Public Device Record Key
34f5f058-c85d-48e5-aae6-7101dc664fba
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 24, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 33 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 63 |