SNC Phantom (FS-QA)
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- SNC Phantom FS-QA EUDAMEDSNC Phantom (FS-QA) FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- SNC Phantom 1252 FS-QA EUDAMEDRadiation therapy, machine QA device FDA UDI
- Model / Reference
- 1252 EUDAMED1252 FS-QA EUDAMED1252300 FDA UDI
- Description
- Radiation therapy, machine QA device FDA UDI
Identifiers
- Catalog Number
- 1252300 FDA UDI
- Primary DI / UDI-DI
- 05060608880812 EUDAMEDFDA UDI
- Basic UDI-DI
- 506060888PHFSQASNCPHCH EUDAMED
- FDA Product Code
- IXG FDA UDI
- EMDN Code
- Z11030599 RADIOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Accelerator system quality assurance device FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.1950 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
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Accelerator system quality assurance device
SNC Phantom (FS-QA) by Sun Nuclear Corporation — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sun Nuclear Corporation
Sources (2)
- FDA UDI 3af4eca7-fa0e-435e-8356-bd32155c0139 35 fields · synced Jul 9, 2026
- EUDAMED 12a089fb-99e1-4b41-9967-d42dd2520431 61 fields · synced Jul 9, 2026