Insight Enhanced DRF Digital Imaging System

System, X-ray, Fluoroscopic, Image-intensified

Imaging Engineering, LLC

The following data is part of a premarket notification filed by Imaging Engineering, Llc with the FDA for Insight Enhanced Drf Digital Imaging System.

Pre-market Notification Details

Device IDK200396
510k NumberK200396
Device Name:Insight Enhanced DRF Digital Imaging System
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant Imaging Engineering, LLC 1318 NW 7th Ave Cape Coral,  FL  33993
ContactGeorge Jachode
CorrespondentGeorge Jachode
Imaging Engineering, LLC 1318 NW 7th Ave Cape Coral,  FL  33993
Product CodeJAA  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-18
Decision Date2020-03-06

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.