Duns Number:622534493
Device Description: CS50 is a Complete System 50 eVIEW Fluoroscopic Imaging system. The Patient table, Positi CS50 is a Complete System 50 eVIEW Fluoroscopic Imaging system. The Patient table, Positioner, X-Ray tube, Image Receptor and Image processor are configurable with interchangeable components that are customer specific resulting in a unit configuration i.e. CS50-P2-G2-T3-I4-A4.
Catalog Number
-
Brand Name
Omega Medical Imaging
Version/Model Number
CS50
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
K100102
Product Code
MQB
Product Code Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Public Device Record Key
934517b8-a1aa-45a1-95d6-3d38d2a1f609
Public Version Date
January 13, 2020
Public Version Number
5
DI Record Publish Date
May 04, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |