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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 K172418
Device Name OpenSight
Applicant
Novarad Corporation
752 East 1180 South #200
American Fork,  UT  84003
Applicant Contact Doug Merrill
Correspondent
Novarad Corporation
752 East 1180 South #200
American Fork,  UT  84003
Correspondent Contact Doug Merrill
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/10/2017
Decision Date 09/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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