Duns Number:017527767
Device Description: Digital X-Ray flat panel detector used to acquire radiographic images of human anatomy whe Digital X-Ray flat panel detector used to acquire radiographic images of human anatomy when used with existing radiographic x-ray systems.
Catalog Number
-
Brand Name
Edge Air
Version/Model Number
Edge Air
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
K172681
Product Code
MQB
Product Code Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Public Device Record Key
ed2b31c5-8028-48d9-8385-6eb35ec6b277
Public Version Date
May 07, 2019
Public Version Number
5
DI Record Publish Date
November 16, 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. | 7 |