System, Image Processing, Radiological

International Medical Solutions Inc.

The following data is part of a premarket notification filed by International Medical Solutions Inc. with the FDA for Cloudvue.

Pre-market Notification Details

Device IDK203058
510k NumberK203058
Device Name:CloudVue
ClassificationSystem, Image Processing, Radiological
Applicant International Medical Solutions Inc. 2425 Matheson Blvd E Mississauga,  CA L4w 5k4
ContactVernon Colaco
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-10-08
Decision Date2020-10-29

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