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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 K142891
Device Name HEPATIQ
Applicant
HEPATIQ LLC
1150 main street, suite e
irvine,  CA  92614
Applicant Contact dipu ghosh
Correspondent
HEPATIQ LLC
1150 main street, suite e
irvine,  CA  92614
Correspondent Contact dipu ghosh
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/03/2014
Decision Date 12/17/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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