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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K192571
Device Name NemoScan
Applicant
Software Nemotec S.L.
Juan De La Cierva St., 66
Arroyomolinos, Madrid,  ES 28939
Applicant Contact Carlos Arias
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/18/2019
Decision Date 12/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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