510(k) K160620 · KPR System, X-Ray, Stationary
Visaris Vision® (Vision C, Vision U. Vision V, Vision X)
| Applicant | Visaris D.O.O. Belgrade, Zemun, RS |
| Decision | Substantially Equivalent, Mar 30, 2016 |
| Received | Mar 4, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160620
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 5, 2018 | Visaris DOO Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2
The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and ter Terminated |
KPR | None listed |
| Apr 5, 2018 | Visaris DOO Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3
The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tert Terminated |
KPR | None listed |
| Apr 5, 2018 | Visaris DOO Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4
The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and ter Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.