Duns Number:557804458
Device Description: 1717SGN is an X-ray image acquisition device that is based on flat-panel. This device shou 1717SGN is an X-ray image acquisition device that is based on flat-panel. This device should be integrated with an operating PC and an X-ray generator. It can do to utilize as digitalizing X-ray images and transfer for radiography diagnostic.
Catalog Number
-
Brand Name
1717SGN
Version/Model Number
1717SGN
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
-
Product Code
MQB
Product Code Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Public Device Record Key
9e7cf0af-1fee-47d5-8e97-fc5e16c7b208
Public Version Date
May 07, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
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 |