VFSS Pro Mobile Digital Imaging System

Interventional Fluoroscopic X-ray System

IMAGExRAY, LLC

The following data is part of a premarket notification filed by Imagexray, Llc with the FDA for Vfss Pro Mobile Digital Imaging System.

Pre-market Notification Details

Device IDK212523
510k NumberK212523
Device Name:VFSS Pro Mobile Digital Imaging System
ClassificationInterventional Fluoroscopic X-ray System
Applicant IMAGExRAY, LLC 160 Park Avenue Nutley,  NJ  07110
ContactGary Korkola
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeOXO
Subsequent Product CodeQHY
Subsequent Product CodeRCC
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-11
Decision Date2021-11-05

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