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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K071195
Device Name KHBS (KRISHNAMURTHY HEPATO-BILIARY SOFTWARE), MODEL VERSION 1.5
Applicant
Ani-Kal Ii, LLC
7570 SW W. Gate Way
Portland,  OR  97225
Applicant Contact GERBAIL T KRISHNAMURTHY, MD
Correspondent
Ani-Kal Ii, LLC
7570 SW W. Gate Way
Portland,  OR  97225
Correspondent Contact GERBAIL T KRISHNAMURTHY, MD
Regulation Number892.1100
Classification Product Code
IYX  
Subsequent Product Code
LLZ  
Date Received04/30/2007
Decision Date 06/20/2007
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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