Sun Nuclear Corporation
Melbourne, FL, US
SUN NUCLEAR CORPORATION appears in FDA device records in Melbourne, FL. FDA records list 24 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Sun Nuclear Corporation between 1988 and 2017. The busiest year on record is 2001, with 3. The most recent is 2017, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 2000 | 2 |
| 2001 | 3 |
| 2002 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 3 |
| 2014 | 3 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K170307 | SunCHECK | IYE | Substantially Equivalent | |
| K161946 | DoseCHECK | IYE | Substantially Equivalent | |
| K160057 | ArcCHECK-MR | IYE | Substantially Equivalent | |
| K142617 | ArcCHECK | IYE | Substantially Equivalent | |
| K150848 | Dose Calculator | IYE | Substantially Equivalent | |
| K142431 | WaterProof PROFILER | IYE | Substantially Equivalent | |
| K142142 | QUALITY REPORTS | IYE | Substantially Equivalent | |
| K141800 | PERFRACTION | IYE | Substantially Equivalent | |
| K131862 | 3DVH | IYE | Substantially Equivalent | |
| K131466 | MAPCHECK2, ARCCHECK | IYE | Substantially Equivalent | |
| K131704 | EPIDOSE | IYE | Substantially Equivalent | |
| K112981 | SUN 125C IONIZATION CHAMBER | LHN | Substantially Equivalent | |
| K101992 | 3D SCANNER, MODEL 1230 | IYE | Substantially Equivalent | |
| K092019 | MODEL 1014 PC ELECTROMETER | IYE | Substantially Equivalent | |
| K063021 | PROFILER 2 | IYE | Substantially Equivalent | |
| K051921 | THE EDGE DETECTOR, MODEL 1118 | IYE | Substantially Equivalent | |
| K013689 | RE-ENTRANT CHAMBER | KPT | Substantially Equivalent | |
| K021463 | MODEL 1133 IVD PC VERSION | IYE | Substantially Equivalent | |
| K011332 | RF-IVD WIRELESS DOSIMETER-MODEL 1133 | IYE | Substantially Equivalent | |
| K011466 | QED DIODE DETECTORS, MODELS 1112-1116 | LNH | Substantially Equivalent | |
| K010449 | IVD (IN VIVO DOSIMETER), MODEL 1131 | IYE | Substantially Equivalent | |
| K002446 | RE-ENTRANT CHAMBER, MODEL 1008 OR 44D | KXK | Substantially Equivalent | |
| K002444 | PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206 | IYE | Substantially Equivalent | |
| K880272 | CAL/RAD UPGRADE MODEL 1030 | KPT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1038814 | 1038814 | SUN NUCLEAR CORPORATION | 3275 Suntree Blvd, Melbourne, FL 32940 US | 2026 | |
| 1121267 | 1121267 | Sun Nuclear Corporation | 900 Asbury Avenue, NORFOLK, VA 23513 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- KPTCalibrator, Dose, Radionuclide
- NNKContainer, Specimen Mailer And Storage, Non-Sterile
- IWZFilm, Radiographic
- LHOInstrument, Quality-Assurance, Radiologic
- IWEMonitor, Patient Position, Light-Beam
- IXGPhantom, Anthropomorphic, Radiographic
- JARPhantom, Test-Pattern, Radionuclide
- KXKSource, Brachytherapy, Radionuclide
- LNHSystem, Nuclear Magnetic Resonance Imaging
- MUJSystem, Planning, Radiation Therapy Treatment
- LHNSystem, Radiation Therapy, Charged-Particle, Medical
- IWBSystem, Radiation Therapy, Radionuclide
- IXFTest-Pattern, Radiographic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0959-2015 | IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device. | Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain