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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 K202718
Device Name Qmenta Care Platform Family
Mint Labs, Inc., d/b/a. QMENTA
One International Place, Suite 3700
Boston,  MA  02110
Applicant Contact Paulo Rodrigues
QMENTA Imaging S.L.
C/ Roger de Lluria 46, Pral. 1 08009
Barcelona,  ES 08009
Correspondent Contact Paulo Rodrigues
Regulation Number892.2050
Classification Product Code
Date Received09/17/2020
Decision Date 06/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No