The following data is part of a premarket notification filed by Visaris D.o.o. Belgrade with the FDA for Visaris Vision® (vision C, Vision U. Vision V, Vision X).
| Device ID | K160620 |
| 510k Number | K160620 |
| Device Name: | Visaris Vision® (Vision C, Vision U. Vision V, Vision X) |
| Classification | System, X-ray, Stationary |
| Applicant | VISARIS D.O.O. BELGRADE BATAJNICKI DRUM 10 DEO 1B Zemun, RS 11080 |
| Contact | Milan Ratkovic |
| Correspondent | Daniel Kamm KAMM & ASSOCIATES 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-04 |
| Decision Date | 2016-03-30 |
| Summary: | summary |