FDA UDI
In Commercial Distribution
🇺🇸 United States
Varex Imaging
DI: 08718755003888
·
Model: ICX1945D
·
Varex Imaging Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Varex Imaging
- Primary DI
- 08718755003888
- Version / Model
- ICX1945D
- Company Name
- Varex Imaging Corporation
- Labeler DUNS
- 080513718
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-25
- Public Version
- 1
- Public Version Date
- 2025-03-05
- Public Version Status
- New
- Public Device Record Key
- a2578556-fd98-442b-a593-4fe5bb906dfc
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | Radiology | 892.1700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38326 | Ionization chamber radiation measuring probe | An electrically isolated or electronically connected gas-filled radiation detection chamber operated in the "ionization chamber" voltage region. It is used with portable survey meters, stationary radiation monitors or analytical counting instruments. The incident radiation sets up a characteristic "saturated current" within the chamber. A number of probes with different size chambers and chamber wall thicknesses are needed to cover the possible range of radiation energies and doses. It is very stable over time and may be used for accurate dosimetry measurements, e.g., source calibrations and inter-comparisons. For accurate measurements, temperature and pressure corrections are needed. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08718755003888 | GS1 |