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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
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