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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 K221870
Device Name CarnaLife Holo
Applicant
MedApp S.A.
Armii Krajowej 25
Krakow,  PL 30-150
Applicant Contact Andrzej Skalski
Correspondent
PAREXEL International
8 Federal Street
Billerica,  MA  01821
Correspondent Contact Albert Pacheco
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/28/2022
Decision Date 05/01/2023
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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