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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Image Processing Software For Radiation Therapy
510(k) Number K212915
Device Name MVision AI Segmentation
Applicant
MVision AI
C/O Terkko Health Hub, Haartmaninkatu 4
Helsinki,  FI 00290
Applicant Contact Kalpana Jha
Correspondent
MVision AI
C/O Terkko Health Hub, Haartmaninkatu 4
Helsinki,  FI 00290
Correspondent Contact Kalpana Jha
Regulation Number892.2050
Classification Product Code
QKB  
Date Received09/13/2021
Decision Date 05/03/2022
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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