HDR microPSD PSD-HB5N
HDR microPSD PSD-HB5N is a medical device (FDA Class II; FDA product code NZT, Dosimeter, Ionizing Radiation, Implanted) made by Radiadyne, L.L.C., listed in FDA GUDID since 8 May 2018 (UDI-DI 00851546007714), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00851546007714 | Date8 May 2018 | StatusListed |
Official records
- AccessGUDID record 00851546007714
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- HDR microPSD
- Generic name
- MOSFET radiation therapy dosimetry system dosimeter
- Model / Ref / Catalog
- PSD-HB5N
- Primary DI / UDI-DI
- 00851546007714
- FDA product code
- NZT
- GMDN term
- MOSFET radiation therapy dosimetry system dosimeter
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices
Other devices filed under FDA product code NZT (Dosimeter, Ionizing Radiation, Implanted).