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 EUDAMED1234 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
- 1234900Z FDA UDI
- Primary DI / UDI-DI
- 05060608881123 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
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
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
- Detector Holder — IBA Dosimetry GmbH · Class II
- myQA®Daily (Software) — IBA Dosimetry GmbH · Class I
- Vista — Modus Medical Devices Inc · Class I
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
European Union Unknown
MDR
United States Pending data
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 (3)
- FDA UDI 8f6cb06b-b124-4fa0-b65e-70b3d9c1299a 35 fields · synced Jul 12, 2026
- EUDAMED 7fa2d668-c35b-49b7-af18-5b444ca0b535-1 61 fields · synced Jul 12, 2026
- EUDAMED 7fa2d668-c35b-49b7-af18-5b444ca0b535-2 61 fields · synced Jul 12, 2026