Duns Number:413223942
Device Description: This is a set consisting out of an AEC sensor from the SolidStateMC series and an amplifie This is a set consisting out of an AEC sensor from the SolidStateMC series and an amplifier from AmpMC-series.
Catalog Number
-
Brand Name
Varex Imaging
Version/Model Number
13774-10
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
IZO
Product Code Name
Generator, High-Voltage, X-Ray, Diagnostic
Public Device Record Key
0874ec22-005d-4e4c-abc6-b33364a277fd
Public Version Date
March 18, 2021
Public Version Number
2
DI Record Publish Date
September 02, 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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 164 |