The following data is part of a premarket notification filed by Dia Imaging Analysis Ltd with the FDA for Lvivo Seamless.
| Device ID | K212466 |
| 510k Number | K212466 |
| Device Name: | LVivo Seamless |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-06 |
| Decision Date | 2021-12-09 |