# K250083: PRO-DOSE System

- Pathway: 510(k) (Traditional)
- Applicant: Nu-Rise, SA
- Decided: Oct 1, 2025 after 261 days
- Product code: NZT (Dosimeter, Ionizing Radiation, Implanted)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K092285 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092285: Portable Dosimeter Dose Verification System, Model TD-RD-90, Best Medical Canada, Ltd. (2009) Summary page 5.

## Indications for use
The PRO-DOSE System is intended to provide dosimetry or detect in real-time the dose delivered to a patient during therapeutic radiation procedures. The system is intended for the verification of the output of HDR brachytherapy after-loaders involving Iridium-192 sources.

Source page: https://510kreport.com/device/K250083
Methodology: https://510kreport.com/methodology