The following data is part of a premarket notification filed by Sit Sordina Iort Technologies Spa with the FDA for Liac Hwl.
| Device ID | K172961 |
| 510k Number | K172961 |
| Device Name: | LIAC HWL |
| Classification | Accelerator, Linear, Medical |
| Applicant | Sit Sordina Iort Technologies Spa Galleria Del Rosso Posso 13 Vicenza, IT 36100 |
| Contact | Alessia Giaffreda |
| Correspondent | Maurizio Pantaleoni Isemed Srl Via P. Togliatti, 19/X Imola, IT 40026 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-26 |
| Decision Date | 2018-06-11 |
| Summary: | summary |