Identity
- Trade Name
- SunCHECK EUDAMEDFDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- SunCHECK EUDAMEDSunCHECK is a software platform intended to collect, detect, compare, calculate, analyze, display, and store radiotherapy quality assurance and dosimetry data. SunCHECK is a server-based Web application which is accessible from any networked PC. It is intended to provide radiation therapy professionals with a platform that integrates patient QA, machine QA and data management workflows. This platform consists of a single GUI and database that is intended to provide a centralized view of a radiation therapy department’s QA efforts. FDA UDI
- Model / Reference
- 1299 EUDAMED1299028 FDA UDI
- Description
- SunCHECK is a software platform intended to collect, detect, compare, calculate, analyze, display, and store radiotherapy quality assurance and dosimetry data. SunCHECK is a server-based Web application which is accessible from any networked PC. It is intended to provide radiation therapy professionals with a platform that integrates patient QA, machine QA and data management workflows. This platform consists of a single GUI and database that is intended to provide a centralized view of a radiation therapy department’s QA efforts. FDA UDI
Identifiers
- Catalog Number
- 1299000-0 FDA UDI
- Primary DI / UDI-DI
- 05060608880348 EUDAMEDFDA UDI
- Basic UDI-DI
- 506060888SWSunCHECKTS EUDAMED
- 510(k) Number
- K170307 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010192 LINEAR ACCELERATORS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiation therapy software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SunCHECK by Sun Nuclear Corporation — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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 | K170307 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 506060888SWSunCHECKTS | 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 (4)
- EUDAMED dbb46032-2812-40fd-b7c0-736501c7171a 85 fields · synced Jul 24, 2026
- FDA UDI d53d94e3-9a38-4704-aa90-cf6608a304a7 35 fields · synced May 30, 2026
- EUDAMED 7f81e60f-a2d5-4401-ae21-7d2839ce0816 61 fields · synced Jul 24, 2026
- FDA 510(k) K170307 1 fields · synced May 18, 2026