NZT · Class II · 21 CFR 892.5050

FDA Product Code NZT: Dosimeter, Ionizing Radiation, Implanted

Verify Radiation Dose To Organs From External Radiation Therapy.

Leading manufacturers include Sicel Technologies, Inc., Radiadyne, LLC and Radiadyne.

7
Total
7
Cleared
128d
Avg days
2008
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 261d recently vs 106d historically

FDA 510(k) Cleared Dosimeter, Ionizing Radiation, Implanted Devices (Product Code NZT)

7 devices
1–7 of 7
Cleared Oct 01, 2025
PRO-DOSE System
K250083
Nu-Rise, SA
Radiology · 261d
Cleared Mar 22, 2019
OARtrac System
K182395
Radialdyne, LLC
Radiology · 199d
Cleared Jun 01, 2017
OARtrac System with Patient Specific Reusable Universal PSD Sensors
K162954
Radiadyne, LLC
Radiology · 220d
Cleared Jun 16, 2015
OARtrac System with Skin Sensors
K150719
Radiadyne, LLC
Radiology · 89d
Cleared Jul 22, 2014
OARTRAC SYSTEM
K141154
Radiadyne
Radiology · 78d
Cleared Nov 13, 2008
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
K083035
Sicel Technologies, Inc.
Radiology · 30d
Cleared Jan 23, 2008
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
K080004
Sicel Technologies, Inc.
Radiology · 21d

About Product Code NZT - Regulatory Context

510(k) Submission Activity

7 total 510(k) submissions under product code NZT since 2008, with 7 receiving FDA clearance (average review time: 128 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - NZT Product Code

Recent submissions under NZT have taken an average of 261 days to reach a decision - up from 106 days historically. Manufacturers should account for longer review timelines in current project planning.

NZT devices are reviewed by the Radiology panel. Browse all Radiology devices →