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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radiological computer-assisted triage and notification software
510(k) Number K193351
Device Name NinesAI
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 Number892.2080
Classification Product Code
QAS  
Date Received12/03/2019
Decision Date 04/21/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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