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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
Applicant
Kinepict Health Ltd
Kelta k z
Budakeszi,  HU 2092
Applicant Contact Lilla Strobel
Correspondent
Kinepict Health Ltd
Kelta k z
Budakeszi,  HU 2092
Correspondent Contact Lilla Strobel
Regulation Number892.2050
Classification Product Code
LLZ  
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
Predetermined Change
Control Plan Authorized		 No
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