OARtrac OT-PSS
OARtrac OT-PSS is a MOSFET radiation therapy dosimetry system (FDA Class II; FDA product code NZT, Dosimeter, Ionizing Radiation, Implanted) made by Radiadyne, L.L.C., cleared under FDA 510(k) K141154 on 22 Jul 2014 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00851546007097), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00851546007097 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141154 | Date22 Jul 2014 | StatusActive |
Official records
- AccessGUDID record 00851546007097
- FDA 510(k) database K141154
Across registries
- FDA 510(k) K141154 decided 22 Jul 2014 Active
- FDA GUDID UDI-DI 00851546007097 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K141154
- Listed FDA GUDID 00851546007097
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- OARtrac
- Generic name
- MOSFET radiation therapy dosimetry system
- Model / Ref / Catalog
- OT-PSS
- Primary DI / UDI-DI
- 00851546007097
- 510(k) Number
- FDA product code
- NZT
- GMDN term
- MOSFET radiation therapy dosimetry system
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code NZT (Dosimeter, Ionizing Radiation, Implanted).