NZT

Dosimeter, Ionizing Radiation, Implanted

Product code
NZT
Device name
Dosimeter, Ionizing Radiation, Implanted
Device class
Class 2
21 CFR
21 CFR 892.5050
Medical specialty
Radiology
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
7 (all years; only the last 3 years are listed here)

FDA classification definition

Verify radiation dose to organs from external radiation therapy.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-10-01.

NumberDecision dateApplicantDevice nameSummary
K2500832025-10-01Nu-Rise, SAPRO-DOSE SystemPDF

1 summaries are archived here for direct download.

Official FDA classification page: NZT
Classification and pathway per current FDA publications. Data from openFDA (CC0).