AIRO Computed Tomography (CT) X-ray System

System, X-ray, Tomography, Computed

Mobius Imaging

The following data is part of a premarket notification filed by Mobius Imaging with the FDA for Airo Computed Tomography (ct) X-ray System.

Pre-market Notification Details

Device IDK160126
510k NumberK160126
Device Name:AIRO Computed Tomography (CT) X-ray System
ClassificationSystem, X-ray, Tomography, Computed
Applicant Mobius Imaging 2 Shaker Road Shirley,  MA  01464
ContactNorma J Lemay
CorrespondentNorma J Lemay
Mobius Imaging 2 Shaker Road Shirley,  MA  01464
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-01-20
Decision Date2016-04-19
Summary:summary

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