SNC Phantom (kV-QA)
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- SNC Phantom 1250 kV-QA EUDAMEDSNC Phantom (kV-QA) FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- SNC Phantom 1250 kV-QA EUDAMEDRadiation therapy, machine QA device FDA UDI
- Model / Reference
- 1250 EUDAMED1250 kV-QA EUDAMED1250300 FDA UDI
- Description
- Radiation therapy, machine QA device FDA UDI
Identifiers
- Catalog Number
- 1250300 FDA UDI
- Primary DI / UDI-DI
- 05060608880782 EUDAMEDFDA UDI
- Basic UDI-DI
- 506060888PH1250kV-QASR 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 (kV-QA) by Sun Nuclear Corp. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Accelerator system quality assurance device.
- Qumulate — Varian Medical Systems, Inc · Class I
- Blue Phantom² — IBA Dosimetry GmbH · Class II
- Standard Imaging QA StereoChecker — STANDARD IMAGING, INC. · Class I
- Detector Holder — IBA Dosimetry GmbH · Class II
- Standard Imaging TomoScanner — STANDARD IMAGING, INC. · Class I
- StereoPHAN — Sun Nuclear Corporation · Class I
- Detector Holder — IBA Dosimetry GmbH · Class II
- myQA®Daily (Software) — IBA Dosimetry GmbH · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sun Nuclear Corp.
Sources (2)
- FDA UDI f8d5be5a-9d48-4933-8759-3e92888a6ac8 35 fields · synced Jun 18, 2026
- EUDAMED 3a662d72-003a-4103-b822-23f4c78c70a3 61 fields · synced Jun 18, 2026