AcuityDRe

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 Acuitydre.

Pre-market Notification Details

Device IDK210919
510k NumberK210919
Device Name:AcuityDRe
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  45409
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-29
Decision Date2021-04-30

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