AIRO CT SYSTEM

System, X-ray, Tomography, Computed

MOBIUS IMAGING, LLC

The following data is part of a premarket notification filed by Mobius Imaging, Llc with the FDA for Airo Ct System.

Pre-market Notification Details

Device IDK131431
510k NumberK131431
Device Name:AIRO CT SYSTEM
ClassificationSystem, X-ray, Tomography, Computed
Applicant MOBIUS IMAGING, LLC 323 WEST MAIN STREET Ayer,  MA  01432
ContactNorma Lemay
CorrespondentNorma Lemay
MOBIUS IMAGING, LLC 323 WEST MAIN STREET Ayer,  MA  01432
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-05-17
Decision Date2013-09-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00869346000200 K131431 000

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