THD Procto Software System THD HRStation
by Thd SpA
THD Procto Software System THD HRStation (800299) is a Class II device made by Thd SpA, cleared under FDA 510(k) K211623 on 24 Jun 2021 and listed in FDA GUDID since 7 Oct 2022 (UDI-DI 58051887042642), active as of 23 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 | Number58051887042642 | Date7 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211623 | Date24 Jun 2021 | StatusActive |
Official records
- AccessGUDID record 58051887042642
- FDA 510(k) database K211623
Across registries
- FDA 510(k) K211623 decided 24 Jun 2021 Active
- FDA GUDID UDI-DI 58051887042642 listed 7 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K211623
- Listed FDA GUDID 58051887042642
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- THD Procto Software System
- Generic name
- Ultrasound imaging system application software
- Model / Ref / Catalog
- THD HRStation, 800299
- Primary DI / UDI-DI
- 58051887042642
- 510(k) Number
- FDA product code
- IYO, KLA, ITX, FWG, OUG, NSX
- GMDN term
- Ultrasound imaging system application software
- Device class
- Class II
- Regulation number
- 892.1560, 876.1725, 892.1570, 878.4160, 880.6310
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Ultrasound imaging system application software.