Identity
- Trade Name
- 1-4MV QED Detector (3m Cable) FDA UDI
- Generic Name
- Solid-state-semiconductor radiation measuring probe FDA UDI
- Device Name
- Radiation therapy QA device. FDA UDI
- Model / Reference
- 11140002Z FDA UDI
- Description
- Radiation therapy QA device. FDA UDI
Identifiers
- Catalog Number
- 11140002Z FDA UDI
- Primary DI / UDI-DI
- B01611140002Z0 FDA UDI
- 510(k) Number
- K011466 FDA UDI
- FDA Product Code
- LNH FDA UDI
- GMDN Term
- Solid-state-semiconductor radiation measuring probe FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
1-4MV QED Detector (3m Cable) by Sun Nuclear Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K011466 also covers:
- QED Detector, 15-25MV (-) 1.5m — SUN NUCLEAR CORP.
- QED Detector, Electron (-) 3m — SUN NUCLEAR CORP.
- QED Detector, Skin (+) 3m — SUN NUCLEAR CORP.
- QED Detector, Skin (-) 1.5m — SUN NUCLEAR CORP.
- QED Detector, 1-4MV (+) 3m — Sun Nuclear Corporation
- QED Detector, 1-4MV (-) 3m — Sun Nuclear Corporation
- QED Detector, 15-25MV (+) 3m — Sun Nuclear Corporation
- QED Detector, 15-25MV (-) 3m — Sun Nuclear Corporation
- QED Detector, 6-12MV (+) 3m — Sun Nuclear Corporation
- QED Detector, 6-12MV (-) 1.5m — Sun Nuclear Corporation
- QED Detector, 6-12MV (-) 3m — Sun Nuclear Corporation
- QED Detector, Electron (+) 3m — Sun Nuclear Corporation
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 II | Pending data |
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Manufacturer
- Manufacturer
- Sun Nuclear Corporation
Sources (1)
- FDA UDI 36bc7e74-c1af-404c-b9f5-e191eb8a4205 37 fields · synced Jun 8, 2026