K250083 is an FDA 510(k) clearance for the PRO-DOSE System. This device is classified as a Dosimeter, Ionizing Radiation, Implanted (Class II - Special Controls, product code NZT).
Submitted by Nu-Rise, SA (Ilhavo, PT). The FDA issued a Cleared decision on October 1, 2025, 261 days after receiving the submission on January 13, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050. Verify Radiation Dose To Organs From External Radiation Therapy..
| 510(k) Number | K250083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2025 |
| Decision Date | October 01, 2025 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | NZT - Dosimeter, Ionizing Radiation, Implanted |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |
| Definition | Verify Radiation Dose To Organs From External Radiation Therapy. |