Identity
- Trade Name
- SNC350p EUDAMEDSNC350p (TNC) FDA UDISNC350p (BNC) FDA UDI
- Generic Name
- Solid-state-semiconductor radiation measuring probe FDA UDI
- Device Name
- SNC350p EUDAMEDRadiation therapy QA device. FDA UDI
- Model / Reference
- 1045 EUDAMED1045400Z FDA UDI1045300Z FDA UDI
- Description
- Radiation therapy QA device. FDA UDI
Identifiers
- Catalog Number
- 1045000-1Z FDA UDI1045000-0Z FDA UDI
- Primary DI / UDI-DI
- 05060608880126 EUDAMEDFDA UDI05060608880232 FDA UDI
- Basic UDI-DI
- 506060888DPSNC350pBF EUDAMED
- 510(k) Number
- K112981 FDA UDI
- FDA Product Code
- LHN FDA UDI
- EMDN Code
- Z11010180 LINEAR ACCELERATORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Solid-state-semiconductor radiation measuring probe FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Solid-state-semiconductor radiation measuring probe
SNC350p (TNC) by Sun Nuclear Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
K112981 also covers:
Manufacturer's product page: SNC125c, SNC350p, SNC600c Proven Reference Ion Chambers
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sun Nuclear Corporation
Sources (3)
- FDA UDI e4be263a-5ddc-411c-81d7-b32855fb57f1 36 fields · synced Jul 29, 2026
- FDA UDI 88e653c7-7820-4daa-a03c-36689c59aa6b 36 fields · synced May 30, 2026
- EUDAMED 4df5a25a-cbbc-4cc2-af28-4dc216b37f8e 61 fields · synced Jul 29, 2026