Duns Number:689842626
Device Description: The EVS 2430W Digital X-ray detector is designed as a digital imaging solution, for provid The EVS 2430W Digital X-ray detector is designed as a digital imaging solution, for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures.
Catalog Number
-
Brand Name
Exprimer
Version/Model Number
EVS 2430W
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MQB
Product Code Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Public Device Record Key
420200a2-bb45-449d-b426-b5e76ae6d8ac
Public Version Date
May 07, 2019
Public Version Number
6
DI Record Publish Date
August 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. | 28 |