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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
Predetermined Change
Control Plan Authorized		 No
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