The following data is part of a premarket notification filed by Thd Spa with the FDA for Thd Procto Software System.
| Device ID | K193512 |
| 510k Number | K193512 |
| Device Name: | THD Procto Software System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | THD SpA Via Dell'Industria, 1 Correggio, IT 42015 |
| Contact | Filippo Bastia |
| Correspondent | Filippo Bastia THD SpA Via Dell'Industria, 1 Correggio, IT 42015 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-18 |
| Decision Date | 2020-01-26 |