FDA product code NZT: Dosimeter, Ionizing Radiation, Implanted
NZT is the FDA product code for dosimeter, ionizing radiation, implanted. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel. FDA has cleared 7 510(k) submissions under NZT, 1 in the last five years, from 5 different applicants. The average 510(k) review took 128 days (median 89); 261 days on average over the last three years. FDA has posted 5 recalls for NZT devices.
Definition
Verify radiation dose to organs from external radiation therapy.
Classification
| Field | Value |
|---|---|
| Device name | Dosimeter, Ionizing Radiation, Implanted |
| Device class | Class II |
| Regulation | 21 CFR 892.5050 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NZT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 220 |
| 2019 | 1 | 199 |
| 2025 | 1 | 261 |
Compare with all 510(k) review times · Search every NZT clearance
Top NZT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Radiadyne, LLC | 2 | 2017-06-01 |
| Sicel Technologies, Inc. | 2 | 2008-11-13 |
| Nu-Rise, SA | 1 | 2025-10-01 |
| Radialdyne, LLC | 1 | 2019-03-22 |
| Radiadyne | 1 | 2014-07-22 |
Most recent NZT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250083 | Nu-Rise, SA | PRO-DOSE System | 2025-10-01 | 261 |
| K182395 | Radialdyne, LLC | OARtrac System | 2019-03-22 | 199 |
| K162954 | Radiadyne, LLC | OARtrac System with Patient Specific Reusable Universal PSD Sensors | 2017-06-01 | 220 |
| K150719 | Radiadyne, LLC | OARtrac System with Skin Sensors | 2015-06-16 | 89 |
| K141154 | Radiadyne | OARTRAC SYSTEM | 2014-07-22 | 78 |
Recalls for NZT devices
5 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-11-19.
| Year | Recalls |
|---|---|
| 2019 | 5 |
Frequently asked questions
What is FDA product code NZT?
NZT is the FDA product code for dosimeter, ionizing radiation, implanted. It is a Class II device, regulated under 21 CFR 892.5050 and reviewed by the Radiology panel.
What device class is NZT?
Class II, regulation 21 CFR 892.5050. Typical premarket route: 510(k).
How long does a 510(k) take for product code NZT?
Across 7 cleared submissions the average was 128 days from receipt to decision (median 89).
Which companies have the most NZT clearances?
Radiadyne, LLC (2); Sicel Technologies, Inc. (2); Nu-Rise, SA (1); Radialdyne, LLC (1); Radiadyne (1).
Have NZT devices been recalled?
Yes: 5 product recalls across 1 recall events; the most recent began 2019-11-19.
Next steps
- Run an FDA pathway report with predicate devices for product code NZT
- Run a recall and safety report across every NZT manufacturer
- Watch product code NZT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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