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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 K202056
Device Name Kinepict Medical Imaging Tool 4.0
Kinepict Health Ltd
Kelta k z
Budakeszi,  HU 2092
Applicant Contact Lilla Strobel
Kinepict Health Ltd
Kelta k z
Budakeszi,  HU 2092
Correspondent Contact Lilla Strobel
Regulation Number892.2050
Classification Product Code
Date Received07/24/2020
Decision Date 09/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No