The following data is part of a premarket notification filed by Diacardio, Ltd. with the FDA for Lvivo Software Application.
| Device ID | K161382 |
| 510k Number | K161382 |
| Device Name: | LVivo Software Application |
| Classification | System, Image Processing, Radiological |
| Applicant | DIACARDIO, LTD. HAENERGIA STREET 77 Be’er Sheva, IL 8496500 |
| Contact | Michal Yaacobi |
| Correspondent | George J. Hattub MEDICSENSE, USA 291 HILLSIDE AVENUE Somerset, MA 02726 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-18 |
| Decision Date | 2016-07-28 |
| Summary: | summary |