Clearance Summary
PRO-DOSE System received FDA 510(k) clearance under submission number K250083, sponsored by Nu-Rise, SA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-10-01.
- Submission: K250083
- Applicant / Sponsor: Nu-Rise, SA
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2025-10-01
Classification & Regulation
This clearance is catalogued under FDA product code NZT and 21 CFR 892.5050, within the Radiology review panel as a Class II device.