The following data is part of a premarket notification filed by Visus Health It Gmbh with the FDA for Jivex (model Number / Release: 5.3).
| Device ID | K212321 |
| 510k Number | K212321 |
| Device Name: | JiveX (Model Number / Release: 5.3) |
| Classification | System, Image Processing, Radiological |
| Applicant | Visus Health IT GmbH Gesundheitscampus-Sued 15-17 Bochum, DE 44801 |
| Contact | Axel Schreiber |
| Correspondent | Axel Schreiber Visus Health IT GmbH Gesundheitscampus-Sued 15-17 Bochum, DE 44801 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-26 |
| Decision Date | 2021-09-23 |