Identity
- Trade Name
- ArcCHECK EUDAMEDFDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- ArcCHECK EUDAMEDRadiation therapy QA device. FDA UDI
- Model / Reference
- 1220 EUDAMED1222300Z FDA UDI
- Description
- Radiation therapy QA device. FDA UDI
Identifiers
- Catalog Number
- 12200000Z FDA UDI
- Primary DI / UDI-DI
- 05060608880027 EUDAMEDFDA UDI
- Basic UDI-DI
- 506060888DAArcCHECKDJ EUDAMED
- FDA Product Code
- IYE 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 UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In 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 Unsafe FDA UDI
Category: Accelerator system quality assurance device
ArcCHECK by Sun Nuclear Corporation — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142617 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 506060888DAArcCHECKDJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sun Nuclear Corporation
- EUDAMED SRN
- US-MF-000020245
- Authorised Representative
- Sun Nuclear GmbH DE-AR-000012933
Sources (3)
- EUDAMED 48f9c4ed-b39e-4a43-b106-0f0e55dc12b6 85 fields · synced Jun 18, 2026
- FDA UDI 17b3f8d3-d4c1-43b0-9f4f-8e546567021d 36 fields · synced May 29, 2026
- FDA 510(k) K142617 1 fields · synced May 18, 2026