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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 K161188
Device Name HEPATIQ 1.1
Applicant
Hepatiq, LLC
1150 Main St., Suite E
Irvine,  CA  92614
Applicant Contact DIPU GHOSH
Correspondent
Hepatiq, LLC
1150 Main St., Suite E
Irvine,  CA  92614
Correspondent Contact DIPU GHOSH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/27/2016
Decision Date 06/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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