Duns Number:437681152
Device Description: X-ray imaging device comprising an X-ray acquisition system, for producing two and three d X-ray imaging device comprising an X-ray acquisition system, for producing two and three dimensional views for computation and display.
Catalog Number
P70720000
Brand Name
NewTom
Version/Model Number
NewTom 5G
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
K142222
Product Code
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
2d299dd7-2b6b-4956-9194-f5bc84a58dde
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 31, 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 |