Identity
- Trade Name
- Varex Imaging FDA UDI
- Generic Name
- Solid-state-semiconductor radiation measuring probe FDA UDI
- Device Name
- The SolidStateMC is an AEC-sensor. (AEC=Automatic Exposure Control) This device is one out of the AmpMC-series. FDA UDI
- Model / Reference
- 13892-10 FDA UDI
- Description
- The SolidStateMC is an AEC-sensor. (AEC=Automatic Exposure Control) This device is one out of the AmpMC-series. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08718755001020 FDA UDI
- FDA Product Code
- IZO FDA UDI
- GMDN Term
- Solid-state-semiconductor radiation measuring probe FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: Solid-state-semiconductor radiation measuring probe
Varex Imaging by Varex Imaging Nederland B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Varex Imaging Nederland B.V.
Sources (1)
- FDA UDI 04e3ed62-dec1-47b4-8269-3cfc0412a0f1 33 fields · synced Jun 8, 2026