The following data is part of a premarket notification filed by Dia Imaging Analysis Ltd with the FDA for Lvivo Software Application.
| Device ID | K210053 |
| 510k Number | K210053 |
| Device Name: | LVivo Software Application |
| Classification | Automated Radiological Image Processing Software |
| Applicant | DiA Imaging Analysis Ltd 77 Haenergia Street Beer-sheva, IL 8470912 |
| Contact | Michal Yaacobi |
| Correspondent | George Hattub Medicsense USA 291 Hillside Avenue Somerset, MA 02726 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-08 |
| Decision Date | 2021-02-05 |