K250083
- 510(k) number
- K250083
- Device name
- PRO-DOSE System
- Applicant
- Nu-Rise, SA PT
- Product code
- NZT — Dosimeter, Ionizing Radiation, Implanted
- Decision date
- 2025-10-01
- Date received
- 2025-01-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250083.pdf
Official FDA record: K250083
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.