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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 K132853
Device Name NOVAPACS
Applicant
NOVARAD CORP.
752 E 1180 S Ste 200
american fork,  UT  84003
Applicant Contact amy hoffman
Correspondent
NOVARAD CORP.
752 E 1180 S Ste 200
american fork,  UT  84003
Correspondent Contact doug merrill
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/12/2013
Decision Date 10/30/2014
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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