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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 K213215
Device Name VSI HoloMedicine
Applicant
ApoQlar GmbH
C/o The-Labs.Space,Raboisen 32
Hamberg,  DE 20095
Applicant Contact Liliana Duarte
Correspondent
ApoQlar GmbH
C/o The-Labs.Space,Raboisen 32
Hamberg,  DE 20095
Correspondent Contact Liliana Duarte
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/29/2021
Decision Date 11/25/2022
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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