Dosimeter, Ionizing Radiation, Implanted
Regulation 892.5050
0510(k)s in 12 months (7 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in NZT
| Company | 510(k)s | Recalls |
|---|---|---|
| Angiodynamics, Inc. | 0 | 5 |
| Radiadyne | 3 | 0 |
| Sicel Technologies, Inc. | 2 | 0 |
| Nu-Rise, SA | 1 | 0 |
| Radialdyne, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 1, 2025 | K250083 | PRO-DOSE System Nu-Rise, SA, PT | NZT |
| Mar 22, 2019 | K182395 | OARtrac System Radialdyne, LLC | NZT |
| Jun 1, 2017 | K162954 | OARtrac System with Patient Specific Reusable Universal PSD Sensors Radiadyne, LLC | NZT |
| Jun 16, 2015 | K150719 | OARtrac System with Skin Sensors Radiadyne, LLC | NZT |
| Jul 22, 2014 | K141154 | OARTRAC SYSTEM Radiadyne | NZT |
| Nov 13, 2008 | K083035 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM Sicel Technologies, Inc. | NZT |
| Jan 23, 2008 | K080004 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM Sicel Technologies, Inc. | NZT |
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