The following data is part of a premarket notification filed by Ebit Srl with the FDA for Suitestensa.
| Device ID | K163668 |
| 510k Number | K163668 |
| Device Name: | SUITESTENSA |
| Classification | System, Image Processing, Radiological |
| Applicant | EBIT Srl Via Melen 77 Genova, IT 16152 |
| Contact | Marco Fruscione |
| Correspondent | Allison Scott Navigant Consulting, Inc. 9001 Wesleyan Road Suite 200 Indianapolis, IN 46268 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-27 |
| Decision Date | 2017-06-23 |
| Summary: | summary |