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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K232698
Device Name NemoScan
Applicant
Software Nemotec S.L.
Av. Juan Caramuel, 1
Leganes,  ES 28919
Applicant Contact Miguel Del Moral
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number892.2050
Classification Product Code
QIH  
Date Received09/05/2023
Decision Date 01/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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