Duns Number:413819707
Device Description: The Zenition 50 with image intensifier is a mobile X-ray imaging and viewing system. It is The Zenition 50 with image intensifier is a mobile X-ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed
Catalog Number
718096
Brand Name
Zenition
Version/Model Number
Zenition 50
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)
Yes
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
K183101
Product Code
JAA
Product Code Name
System, X-Ray, Fluoroscopic, Image-Intensified
Public Device Record Key
c53886a8-3fee-4caf-beff-47ce4a08fe31
Public Version Date
September 23, 2019
Public Version Number
2
DI Record Publish Date
April 04, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 349 |