RESOLUTIONMD MOBILE

System, Image Processing, Radiological

CALGARY SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Calgary Scientific, Inc. with the FDA for Resolutionmd Mobile.

Pre-market Notification Details

Device IDK133508
510k NumberK133508
Device Name:RESOLUTIONMD MOBILE
ClassificationSystem, Image Processing, Radiological
Applicant CALGARY SCIENTIFIC, INC. SUITE 208, 1210 20TH AVENUE SE Calgary, Alberta,  CA T2g 1m8
ContactKyle Peterson
CorrespondentKyle Peterson
CALGARY SCIENTIFIC, INC. SUITE 208, 1210 20TH AVENUE SE Calgary, Alberta,  CA T2g 1m8
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-14
Decision Date2014-03-26
Summary:summary

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