Duns Number:687967554
Device Description: Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is int Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Catalog Number
-
Brand Name
NA
Version/Model Number
F4335-AW
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
K222353
Product Code
MQB
Product Code Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Public Device Record Key
3789dda8-ca97-49e1-8f3e-2d4dfa3af660
Public Version Date
October 28, 2022
Public Version Number
1
DI Record Publish Date
October 20, 2022
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |