Duns Number:557804458
Device Description: 1417WCC is a digital X-ray flat panel detector that can acquire radiographic images of hum 1417WCC is a digital X-ray flat panel detector that can acquire radiographic images of human anatomy when used with existing radiographic x-ray systems
Catalog Number
-
Brand Name
1417WCC
Version/Model Number
1417WCC
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
K171418
Product Code
MQB
Product Code Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Public Device Record Key
ff820b32-51f7-460f-a8d2-52b8b8979399
Public Version Date
March 16, 2020
Public Version Number
5
DI Record Publish Date
July 06, 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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 110 |