Company ยท US
Sun Nuclear Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2017. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 25, 2017 | K170307 | SunCHECK Sun Nuclear Corporation | IYE |
| Sep 16, 2016 | K161946 | DoseCHECK Sun Nuclear Corporation | IYE |
| May 13, 2016 | K160057 | ArcCHECK-MR Sun Nuclear Corporation | IYE |
| Nov 20, 2015 | K142617 | ArcCHECK Sun Nuclear Corporation | IYE |
| May 20, 2015 | K150848 | Dose Calculator Sun Nuclear Corporation | IYE |
| Dec 5, 2014 | K142431 | WaterProof PROFILER Sun Nuclear Corporation | IYE |
| Dec 5, 2014 | K142142 | QUALITY REPORTS Sun Nuclear Corporation | IYE |
| Sep 26, 2014 | K141800 | PERFRACTION Sun Nuclear Corporation | IYE |
| Aug 21, 2013 | K131862 | 3DVH Sun Nuclear Corporation | IYE |
| Aug 20, 2013 | K131466 | MAPCHECK2, ARCCHECK Sun Nuclear Corporation | IYE |
| Aug 5, 2013 | K131704 | EPIDOSE Sun Nuclear Corporation | IYE |
| Jan 25, 2012 | K112981 | SUN 125C IONIZATION CHAMBER Sun Nuclear Corp. | LHN |
| Oct 1, 2010 | K101992 | 3D SCANNER, MODEL 1230 Sun Nuclear Corp. | IYE |
| Sep 15, 2009 | K092019 | MODEL 1014 PC ELECTROMETER Sun Nuclear Corp. | IYE |
| Nov 22, 2006 | K063021 | PROFILER 2 Sun Nuclear Corp. | IYE |
| Jul 27, 2005 | K051921 | THE EDGE DETECTOR, MODEL 1118 Sun Nuclear Corp. | IYE |
| Jul 2, 2002 | K013689 | RE-ENTRANT CHAMBER Sun Nuclear Corp. | KPT |
| Jun 6, 2002 | K021463 | MODEL 1133 IVD PC VERSION Sun Nuclear Corp. | IYE |
| Jul 26, 2001 | K011332 | RF-IVD WIRELESS DOSIMETER-MODEL 1133 Sun Nuclear Corp. | IYE |
| Jun 6, 2001 | K011466 | QED DIODE DETECTORS, MODELS 1112-1116 Sun Nuclear Corp. | LNH |
| May 4, 2001 | K010449 | IVD (IN VIVO DOSIMETER), MODEL 1131 Sun Nuclear Corp. | IYE |
| Oct 23, 2000 | K002446 | RE-ENTRANT CHAMBER, MODEL 1008 OR 44D Sun Nuclear Corp. | KXK |
| Oct 18, 2000 | K002444 | PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206 Sun Nuclear Corp. | IYE |
| Feb 29, 1988 | K880272 | CAL/RAD UPGRADE MODEL 1030 Sun Nuclear Corp. | KPT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2015 | Sun Nuclear Corporation 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. Terminated |
IYE | None listed |