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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 K211279
Device Name Volpara Imaging Software
Applicant
Volpara Health Technologies Limited
Level 14-15, Simpl House,
40 Mercer Street, Wellington Central
Wellington,  NZ 6011
Applicant Contact Ralph Highnam
Correspondent
Volpara Health Technologies Limited
Level 14-15, Simpl House,
40 Mercer Street, Wellington Central
Wellington,  NZ 6011
Correspondent Contact Ralph Highnam
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/27/2021
Decision Date 07/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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