FDA Product Code
FDA Product Code NZT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5050
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250083 | PRO-DOSE System | Nu-Rise, SA | 2025-10-01 | Traditional | PDF ↗ |
| K182395 | OARtrac System | Radialdyne, LLC | 2019-03-22 | Traditional | PDF ↗ |
| K162954 | OARtrac System with Patient Specific Reusable Universal PSD Sensors | Radiadyne, LLC | 2017-06-01 | Traditional | PDF ↗ |
| K150719 | OARtrac System with Skin Sensors | Radiadyne, LLC | 2015-06-16 | Traditional | PDF ↗ |
| K141154 | OARTRAC SYSTEM | Radiadyne | 2014-07-22 | Traditional | PDF ↗ |
| K083035 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM | Sicel Technologies, Inc. | 2008-11-13 | Special | PDF ↗ |
| K080004 | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM | Sicel Technologies, Inc. | 2008-01-23 | Special | PDF ↗ |
Product code NZT · Class II · Radiology. Data: openFDA.