The following data is part of a premarket notification filed by Thd Spa with the FDA for Thd Procto Software System.
| Device ID | K211623 |
| 510k Number | K211623 |
| Device Name: | THD Procto Software System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | THD SpA Via Dell'Industria, 1 Correggio, IT 42015 |
| Contact | Maurizio Pantaleoni |
| Correspondent | Maurizio Pantaleoni THD SpA Via Dell'Industria, 1 Correggio, IT 42015 |
| Product Code | IYO |
| Subsequent Product Code | FWG |
| Subsequent Product Code | ITX |
| Subsequent Product Code | KLA |
| Subsequent Product Code | NSX |
| Subsequent Product Code | OUG |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-26 |
| Decision Date | 2021-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18033737712389 | K211623 | 000 |
| 08033737713037 | K211623 | 000 |
| 58051887042642 | K211623 | 000 |
| 18033737712341 | K211623 | 000 |
| 68051887043325 | K211623 | 000 |
| 68051887043318 | K211623 | 000 |
| 68051887043301 | K211623 | 000 |
| 68051887043295 | K211623 | 000 |