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
P70720008
Brand Name
NewTom
Version/Model Number
NewTom 5G XL
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
K183448
Product Code
JAK
Product Code Name
System, X-Ray, Tomography, Computed
Public Device Record Key
cc662afa-7733-4ee3-bb96-e26fff5d8a71
Public Version Date
April 09, 2019
Public Version Number
1
DI Record Publish Date
April 01, 2019
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 |