Duns Number:428658934
Device Description: The detector is suitable for acquiring digital images in radiography modes. It allows radi The detector is suitable for acquiring digital images in radiography modes. It allows radiological diagnostic examinations to be performed in real time. The acquired images are saved in the system memory, displayed on a high definition monitor (HD) and eventually transmitted to a diagnostic workstation. An intermediate storage of images is performed if a wireless connection is not available.
Catalog Number
-
Brand Name
THALES
Version/Model Number
Pixium 3543EZ
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
K213081
Product Code
MQB
Product Code Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Public Device Record Key
5dfcacf2-1655-4f6e-b4e9-a24630a6e819
Public Version Date
December 23, 2021
Public Version Number
5
DI Record Publish Date
February 10, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |