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
- 12838-10 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
- 08718755000993 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
Similar devices
Also classified as Solid-state-semiconductor radiation measuring probe.
- ISORAD Detector, 15-25MV (+) 3m — Sun Nuclear Corporation · Class II
- REFERENCE DETECTOR (BNC) — Sun Nuclear Corporation · Class I
- ISORAD Detector, 15-25MV (-) 3m — SUN NUCLEAR CORP. · Class II
- QED Detector, Skin (-) 3m — Sun Nuclear Corporation · Class II
- QED Detector, Electron (-) 1.5m — Sun Nuclear Corporation · Class II
- rf-IVD 2 — SUN NUCLEAR CORP. · Class II
- SNC350p (TNC) — Sun Nuclear Corporation · Class II
- ISORAD Detector, 15-25MV (-) 1.5m — Sun Nuclear Corporation · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Varex Imaging Nederland B.V.
Sources (1)
- FDA UDI c184297c-767c-46a1-ac0f-81c58e375cbd 33 fields · synced May 30, 2026