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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
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