NZT
7 FDA 510(k) clearances · Product code
89 daysmedian time to decision
261 days90th percentile
7clearances measured
FDA profile
- Official device name
- Dosimeter, Ionizing Radiation, Implanted
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.5050
- Medical specialty
- Radiology
- Flags
- Implant
- FDA definition
- Verify radiation dose to organs from external radiation therapy.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PRO-DOSE System (K250083) | Nu-Rise, SA | 2025-10-01 |
| OARtrac System (K182395) | Radialdyne, LLC | 2019-03-22 |
| OARtrac System with Patient Specific Reusable Universal PSD Sensors (K162954) | Radiadyne, LLC | 2017-06-01 |
| OARtrac System with Skin Sensors (K150719) | Radiadyne, LLC | 2015-06-16 |
| OARTRAC SYSTEM (K141154) | Radiadyne | 2014-07-22 |
| DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (K083035) | Sicel Technologies, Inc. | 2008-11-13 |
| DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (K080004) | Sicel Technologies, Inc. | 2008-01-23 |
Track NZT automatically
Every clearance here is in the API, with alerts when new ones post.