KDR AU-DDR System Advanced U-Arm With Dynamic Digital Radiography, KDR AU System Advanced U-Arm With Static Digital Radiography

System, X-ray, Stationary

Konica Minolta Healthcare Americas, Inc

The following data is part of a premarket notification filed by Konica Minolta Healthcare Americas, Inc with the FDA for Kdr Au-ddr System Advanced U-arm With Dynamic Digital Radiography, Kdr Au System Advanced U-arm With Static Digital Radiography.

Pre-market Notification Details

Device IDK193225
510k NumberK193225
Device Name:KDR AU-DDR System Advanced U-Arm With Dynamic Digital Radiography, KDR AU System Advanced U-Arm With Static Digital Radiography
ClassificationSystem, X-ray, Stationary
Applicant Konica Minolta Healthcare Americas, Inc 2217 US Highway 70 East Gamer,  NC  27529
ContactJan Maniscalco
CorrespondentJan Maniscalco
Konica Minolta Healthcare Americas, Inc 2217 US Highway 70 East Gamer,  NC  27529
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-22
Decision Date2020-01-15

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