The following data is part of a premarket notification filed by Visus Health It Gmbh with the FDA for Jivex.
| Device ID | K181964 |
| 510k Number | K181964 |
| Device Name: | JiveX |
| 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 | 2018-07-23 |
| Decision Date | 2018-10-23 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() JIVEX 76318064 2876014 Live/Registered |
VISUS HEALTH IT GMBH 2001-09-27 |