The following data is part of a premarket notification filed by Sit Sordina Iort Technologies Spa with the FDA for Liac S.
Device ID | K182374 |
510k Number | K182374 |
Device Name: | LIAC S |
Classification | Accelerator, Linear, Medical |
Applicant | Sit Sordina Iort Technologies Spa Galleria Del Rosso Pozzo 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 | 2018-08-31 |
Decision Date | 2019-05-22 |