Identity
- Trade Name
- SunSCAN 3D System EUDAMEDSunSCAN 3D FDA UDI
- Generic Name
- Accelerator system quality assurance device FDA UDI
- Device Name
- SunSCAN 3D System EUDAMEDThe SunSCAN 3D, model 1234/1235, is intended for radiotherapy dosimetry measurements and export of those measurements for commissioning a Treatment Planning System (TPS) computer. It is also intended for periodic beam Quality Assurance (QA) tests as defined by the medical physicist responsible for the QA program. FDA UDI
- Model / Reference
- 1234, 1235 EUDAMED1325 EUDAMED1235 FDA UDI
- Description
- The SunSCAN 3D, model 1234/1235, is intended for radiotherapy dosimetry measurements and export of those measurements for commissioning a Treatment Planning System (TPS) computer. It is also intended for periodic beam Quality Assurance (QA) tests as defined by the medical physicist responsible for the QA program. FDA UDI
Identifiers
- Catalog Number
- 1235900Z FDA UDI
- Primary DI / UDI-DI
- 05060608881130 EUDAMEDFDA UDI
- Basic UDI-DI
- 506060888WTSunSCAN3D3G EUDAMED
- 510(k) Number
- K101992 FDA UDI
- 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
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
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Accelerator system quality assurance device
SunSCAN 3D by Sun Nuclear Corporation — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Accelerator system quality assurance device.
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- Detector Holder — IBA Dosimetry GmbH · Class II
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- Detector Holder — IBA Dosimetry GmbH · Class II
- myQA®Daily (Software) — IBA Dosimetry GmbH · Class I
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Cleared under the same submission
K101992 also covers:
- 3D MiniLift — SUN NUCLEAR CORP.
- 3D SCANNER (BNC) — SUN NUCLEAR CORP.
- 3D Reservoir — Sun Nuclear Corporation
- 3D Reservoir — Sun Nuclear Corporation
- 3D SCANNER (TNC) — Sun Nuclear Corporation
- 3D SCANNER (TNC) — Sun Nuclear Corporation
- 3D TPR — Sun Nuclear Corporation
- Halcyon Bracket — Sun Nuclear Corporation
- Halcyon Couch Positioning Plate — Sun Nuclear Corporation
- SunSCAN 3D — Sun Nuclear Corporation
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sun Nuclear Corporation
Sources (2)
- FDA UDI 3fc718af-46bf-4f57-bb0d-8e78b2f8672a 35 fields · synced Jul 10, 2026
- EUDAMED 1f03fbe7-8716-4d76-abbc-4f0a46dfc899 61 fields · synced Jul 10, 2026