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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 K202990
Device Name NinesMeasure
Applicant
Nines, Inc.
329 Alma St.
Palo Alto,  CA  94301
Applicant Contact Russell Stewart
Correspondent
Hogan Lovells US LLP
555 13th Street, NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/30/2020
Decision Date 02/25/2021
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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