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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 K171754
Device Name NovaPACS
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 Received06/13/2017
Decision Date 07/28/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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