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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 K211788
Device Name HALO
Applicant
Nico.Lab B.V.
Paasheuvelweg 25
Amsterdam,  NL 1105 BP
Applicant Contact Merel Boers
Correspondent
MD Squared B.V.
High Tech Campus 29
Eindhoven,  NL 5656 AE
Correspondent Contact Ruojuan Zhang
Regulation Number892.2080
Classification Product Code
QAS  
Date Received06/09/2021
Decision Date 07/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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