Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Konica MinoltaLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Viztek with 11 510(k) clearances. The most recent is a 510(k) clearance dated May 20, 2016: ViZion DR + Wireless.
| May 20, 2016 | ViZion DR + WirelessK160810 · MQB | 510(k) clearances |
| Sep 10, 2015 | ViZion DR + WirelessK152279 · MQB | 510(k) clearances |
| Dec 16, 2014 | EXAK142919 · LLZ | 510(k) clearances |
| Apr 3, 2014 | VIZION ULTRAK133139 · MQB | 510(k) clearances |
| Jan 11, 2013 | VIZION + DRK123644 · MQB | 510(k) clearances |
| Oct 20, 2011 | VIZION DRK112661 · MQB | 510(k) clearances |
| Jan 24, 2011 | VIZION DRK102123 · KPR | 510(k) clearances |
| Nov 12, 2009 | VIZTEK WLK091752 · KPR | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
