FDA Registration
Active
🇺🇸 United States
SUN NUCLEAR CORPORATION
Reg #: 1038814
·
FEI: 1038814
·
Expires 2026
Products
8
Proprietary Names
57
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- SUN NUCLEAR CORPORATION
- Registration Number
- 1038814
- FEI Number
- 1038814
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3275 Suntree Blvd
- City
- Melbourne
- State
- FL
- ZIP
- 32940
- Country
- US
Regulatory Submissions
- 510(k) Number
- K051921
Owner / Operator
- Firm Name
- SUN NUCLEAR CORPORATION
- Operator Number
- 10028193
- Address
- 3275 Suntree Boulevard
- City
- Melbourne
- State
- FL
- Postal Code
- 32940
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2009-01-07 |
| System, Planning, Radiation Therapy Treatment | MUJ | Class 2 | Radiology | No | 2025-05-22 |
| Monitor, Patient Position, Light-Beam | IWE | Class 1 | Radiology | No | 2024-11-14 |
| System, Radiation Therapy, Radionuclide | IWB | Class 2 | Radiology | No | 2009-01-07 |
| System, Radiation Therapy, Charged-Particle, Medical | LHN | Class 2 | Radiology | No | 2014-03-06 |
| Instrument, Quality-Assurance, Radiologic | LHO | Class 1 | Radiology | No | 2009-01-07 |
| Phantom, Anthropomorphic, Radiographic | IXG | Class 1 | Radiology | No | 2011-08-24 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2009-01-07 |
Proprietary Names
1049 - SunSILICON P
1048 - SunSILICON
1118 - EDGE DETECTOR
1057 - Plan AI
1178 - MapCHECK 3
1179 - SRS MapCHECK
1215 - PerFRACTION
1136 - rf-IVD (WIRELESS)
1014 - PC Electrometer
1220 - ArcCHECK
1299 - SunCHECK
MICRO+
MICRO
CT SIM+
1203 - WaterProof PROFILER
1216 - PlanIQ
1218 - Dose Calculator
1174 - PROFILER2
1137 - IVD (WIRED)
1162 - ISORAD
1164 - ISORAD
1163 - ISORAD
1230 - 3D SCANNER
1234/1235 - SunSCAN 3D
1047 - SNC600c
1045 - SNC350p
1041 - SNC125c
1212 - 3DVH
1220-2 - MultiPlug
1098 - Daily QA 4 Pro Wireless
1231 - 1D SCANNER
1176 - TomoDOSE
1093-MR - Daily QA-MR
1233 -1D SCANNER
1046 - Reference Detector
1098 - Daily QA 4 Pro
1093 - rf-Daily QA 3
1220-1 - CavityPlug
1122 - IC PROFILER
1122-MR - IC PROFILER-MR
1220-3 - PMMA MultiPlug
1093 - Daily QA 3
1220 - ArcCHECK-MR
1253 - SNC Phantom WL-QA
1252 - SNC Phantom FS-QA
1083 - MapPHAN
1255 - StereoPHAN
1257 - MultiMet-WL QA
1250 - SNC Phantom kV-QA
1280 - Alignment Verification Accessory (AVa)
1251 - SNC Phantom MV-QA
1113 - QED
1116 - QED
1114 - QED
1112 - QED
1115 - QED
1217 - DoseCHECK
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198