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

Radmedix LLC

The following data is part of a premarket notification filed by Radmedix Llc with the FDA for Accuvue+.

Pre-market Notification Details

Device IDK201058
510k NumberK201058
Device Name:Accuvue+
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Radmedix LLC 2510 Lance Dr. Dayton,  OH  45409
ContactGabriel Issa
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-21
Decision Date2020-05-06

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