Identity
- Trade Name
- SNC600c EUDAMEDSNC600c (BNC) FDA UDISNC600c (TNC) FDA UDI
- Generic Name
- Solid-state-semiconductor radiation measuring probe FDA UDI
- Device Name
- SNC600c EUDAMEDRadiation therapy QA device. FDA UDI
- Model / Reference
- 1047 EUDAMED10470000Z FDA UDI1047400Z FDA UDI1047300Z FDA UDI
- Description
- Radiation therapy QA device. FDA UDI
Identifiers
- Catalog Number
- 10470000Z FDA UDI1047000-1Z FDA UDI1047000-0Z FDA UDI
- Primary DI / UDI-DI
- 05060608880249 EUDAMEDFDA UDI05060608880133 EUDAMEDFDA UDIB01610470000Z0 FDA UDI
- Basic UDI-DI
- 506060888DPSNC600cAH 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
- Not in Commercial Distribution FDA UDIIn Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
MR Conditional FDA UDI
SNC600c (BNC) by Sun Nuclear Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
Manufacturer's product page: SNC125c, SNC350p, SNC600c Proven Reference Ion Chambers
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 |
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Manufacturer
- Manufacturer
- Sun Nuclear Corporation
Sources (5)
- FDA UDI 76f4fe85-610e-456a-a3b3-19bf59df97a7 37 fields · synced Aug 4, 2026
- FDA UDI 3c472cbf-0628-4398-a1bd-8d5ab500b187 36 fields · synced May 30, 2026
- FDA UDI 894f7a6c-af15-4f98-892e-71617adc4ce8 36 fields · synced May 30, 2026
- EUDAMED f553d93a-ffed-4f86-97ff-039718d865f4 61 fields · synced Jul 8, 2026
- EUDAMED 69e86e78-c21a-4c19-ab72-246bfe500bd3 61 fields · synced Aug 4, 2026