ArcCHECK-MR
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- ArcCHECK-MR EUDAMEDFDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- ArcCHECK EUDAMEDRadiation therapy QA device. FDA UDI
- Model / Reference
- 1220 EUDAMED1220-MR EUDAMED12200000MR FDA UDI
- Description
- Radiation therapy QA device. FDA UDI
Identifiers
- Catalog Number
- 12200000MR FDA UDI
- Primary DI / UDI-DI
- 05060608880355 EUDAMEDFDA UDI
- Basic UDI-DI
- 506060888DAArcCHECKDJ EUDAMED
- 510(k) Number
- FDA Product Code
- IYE FDA 510(k)FDA UDI
- EMDN Code
- Z11010180 LINEAR ACCELERATORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Accelerator system quality assurance device FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
The ArcCHECK-MR is a quality assurance phantom designed for the verification and commissioning of linear accelerator-based radiation therapy systems, including those used in MRI-guided radiotherapy. It provides a standardized method to assess dose distributions, beam alignment, and treatment planning accuracy in clinical environments where magnetic resonance imaging compatibility is required.
This device is intended for use in radiation oncology departments and is supplied as a reusable, non-sterile phantom. It is compatible with MRI environments and is available in specific configurations to accommodate various linear accelerator models. Authorized under FDA 510(k) and MDR regulations, the ArcCHECK-MR adheres to regulatory standards for medical radiation devices, ensuring compliance with safety and performance requirements.
Frequently asked questions
What is the ArcCHECK-MR primarily used for in a clinical setting?
The ArcCHECK-MR is designed for quality assurance in radiation therapy, specifically to verify and commission linear accelerator-based systems—including those used in MRI-guided radiotherapy. It helps assess dose distributions, beam alignment, and treatment planning accuracy in environments where MRI compatibility is essential.
Is the ArcCHECK-MR intended for single-use or reusable applications?
The ArcCHECK-MR is supplied as a reusable phantom, meaning it is designed for repeated use in clinical settings. It is not intended for single-use and should be properly cleaned and maintained between uses.
Does the ArcCHECK-MR come in different configurations or sizes?
Yes, the ArcCHECK-MR is available in specific configurations tailored to accommodate various linear accelerator models. While exact sizes or models aren’t detailed in the data, its design ensures compatibility with multiple systems used in radiation therapy.
How is the ArcCHECK-MR regulated, and what does that mean for buyers?
The ArcCHECK-MR is authorized under both FDA 510(k) and MDR (Medical Device Regulation) pathways, indicating it has undergone regulatory review to demonstrate safety and performance. This means buyers can rely on its compliance with established standards for medical radiation devices, ensuring it meets necessary quality and safety criteria.
Is the ArcCHECK-MR compatible with MRI environments, and why does that matter?
Yes, the ArcCHECK-MR is explicitly designed for MRI-guided radiotherapy environments. This compatibility ensures it can be safely used alongside MRI systems without interference, which is critical for accurate dose verification and treatment planning in hybrid MRI-radiation therapy setups.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K160057 | Class II | Active |
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Manufacturer
- Manufacturer
- Sun Nuclear Corporation
Sources (3)
- FDA 510(k) K160057 24 fields · synced Sep 18, 2026
- FDA UDI 6f7984a6-1c8a-42a1-aac6-e038528039f0 36 fields · synced May 30, 2026
- EUDAMED cc3cbf20-06ef-4904-bc92-d458251ff2e0 61 fields · synced Jul 8, 2026