VIZION + DR

Solid State X-ray Imager (flat Panel/digital Imager)

VIZTEK LLC

The following data is part of a premarket notification filed by Viztek Llc with the FDA for Vizion + Dr.

Pre-market Notification Details

Device IDK123644
510k NumberK123644
Device Name:VIZION + DR
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant VIZTEK LLC 8870 RAVELLO CT Naples,  FL  34114
ContactDaniel Kamm, P.e.
CorrespondentDaniel Kamm, P.e.
VIZTEK LLC 8870 RAVELLO CT Naples,  FL  34114
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-26
Decision Date2013-01-11
Summary:summary

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