Duns Number:113928654
Device Description: Mobile X-Ray System for General Purpose Radiography Exams Utilizing Film, Computed Radiogr Mobile X-Ray System for General Purpose Radiography Exams Utilizing Film, Computed Radiography, or Direct Digital Flat Panels
Catalog Number
900117
Brand Name
UC-5000
Version/Model Number
UC-5000
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
K163063
Product Code
IZL
Product Code Name
System, X-Ray, Mobile
Public Device Record Key
6fffed1d-66ba-469a-a566-618fea1b325e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |