Product code NZT— Radiology
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
- Classification name
- Dosimeter, Ionizing Radiation, Implanted
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Total cleared
- 7
- First cleared
- Most recent
FDA classification definition
“Verify radiation dose to organs from external radiation therapy.”
Market context for product code NZT
FDA has cleared devices under product code NZT between 2008 and 2025, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2019
- 2017
- 2015
- 2014
- 2008
Top applicants under product code NZT
Recent clearances under product code NZT
- K250083 — PRO-DOSE System
- K182395 — OARtrac System
- K162954 — OARtrac System with Patient Specific Reusable Universal PSD Sensors
- K150719 — OARtrac System with Skin Sensors
- K141154 — OARTRAC SYSTEM
- K083035 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
- K080004 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.