Asimov-MKS Imaging System

System, X-ray, Angiographic

OnLume Inc.

The following data is part of a premarket notification filed by Onlume Inc. with the FDA for Asimov-mks Imaging System.

Pre-market Notification Details

Device IDK192761
510k NumberK192761
Device Name:Asimov-MKS Imaging System
ClassificationSystem, X-ray, Angiographic
Applicant OnLume Inc. 3300 Commercial Ave Madison,  WI  53714
ContactGreg Bange
CorrespondentGreg Bange
OnLume Inc. 3300 Commercial Ave Madison,  WI  53714
Product CodeIZI  
CFR Regulation Number892.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelGeneral & Plastic Surgery
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2020-01-17

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