Identity
- Trade Name
- QED Detector, Skin (-) 3m FDA UDI
- Generic Name
- Solid-state-semiconductor radiation measuring probe FDA UDI
- Device Name
- Radiation therapy QA device FDA UDI
- Model / Reference
- 11130002Z FDA UDI
- Description
- Radiation therapy QA device FDA UDI
Identifiers
- Catalog Number
- 11130002Z FDA UDI
- Primary DI / UDI-DI
- 05060608880416 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
- 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
Category: Solid-state-semiconductor radiation measuring probe
QED Detector, Skin (-) 3m by Sun Nuclear Corporation — Class II — 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 CORP. · Class II
- Varex Imaging — Varex Imaging Nederland B.V. · Class I
- Varex Imaging — Varex Imaging Nederland B.V. · Class I
- rf-IVD 2 — SUN NUCLEAR CORP. · Class II
- Varex Imaging — Varex Imaging Nederland B.V. · Class I
- Varex Imaging — Varex Imaging Nederland B.V. · Class I
- Varex Imaging — Varex Imaging Nederland B.V. · Class I
- ISORAD Detector, 1-4MV (-) 3m — SUN NUCLEAR CORP. · Class II
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 53d14c9a-2f44-45cf-b07e-026c55526af7 36 fields · synced Jun 8, 2026