Identity
- Trade Name
- Varex Imaging EUDAMEDFDA UDI
- Generic Name
- Ionization chamber radiation measuring probe FDA UDI
- Device Name
- Ionization Chamber series MDD EUDAMEDAn 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. FDA UDI
- Model / Reference
- ICX996B EUDAMEDFDA UDI165586 EUDAMED
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718755002560 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08718755002560 EUDAMED
- FDA Product Code
- IZO FDA UDI
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Ionization chamber radiation measuring probe FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass I FDA UDI
- Regulation Number
- 892.1700 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ionization chamber radiation measuring probe
Varex Imaging by Varex Imaging Corporation — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Varex Imaging Corporation
Sources (2)
- FDA UDI e4e25c24-c0ad-4477-8af9-5d4ab7e9c634 33 fields · synced Jun 18, 2026
- EUDAMED 47e20409-fa85-4ffe-9015-42720c6521dd 61 fields · synced Jun 18, 2026