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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 K063153
Device Name NOVAPACS
Applicant
Novarad Corp.
758 E. Utah Valley Dr.
Suite 200
American Fork,  UT  84003
Applicant Contact PAUL SHUMWAY
Correspondent
Novarad Corp.
758 E. Utah Valley Dr.
Suite 200
American Fork,  UT  84003
Correspondent Contact PAUL SHUMWAY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/16/2006
Decision Date 12/07/2006
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
Recalls CDRH Recalls
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