Duns Number:080513718
Device Description: An Ionization Chamber is a device that is placed between the patient and an x-ray image re An Ionization Chamber is a device that is placed between the patient and an x-ray image receptor to assist the Automatic Exposure Control (AEC) in delivering the proper x-ray dose in medical radiography.This is a device out of the Ionization Chambers series.
Catalog Number
-
Brand Name
Varex Imaging
Version/Model Number
ICX555B
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
22ff3ce6-76ef-46db-82f0-a885b8ac6792
Public Version Date
March 14, 2022
Public Version Number
1
DI Record Publish Date
March 04, 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 | 68 |