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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 K153427
Device Name Volpara Imaging Software
Applicant
Matakina Technology, Ltd.
Level 12 86 Victoria St.
Wellington,  NZ 6011
Applicant Contact Ralph Highnam
Correspondent
Matakina Technology, Ltd.
Level 12 86 Victoria St.
Wellington,  NZ 6011
Correspondent Contact Ralph Highnam
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/25/2015
Decision Date 01/07/2016
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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