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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Triage And Notification Software
510(k) Number K200873
Device Name HALO
Applicant
NICo-Lab B.V.
Paasheuvelweg 25
Amsterdam,  NL 1105BP
Applicant Contact Merel Boers
Correspondent
MD Squared B.V.
High Tech Campus 29
Eindhoven,  NL 5858AE
Correspondent Contact Roujuan Zhang
Regulation Number892.2080
Classification Product Code
QAS  
Date Received04/01/2020
Decision Date 11/20/2020
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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