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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 K241490
Device Name Contour+ (MVision AI Segmentation)
Applicant
Mvision AI OY
Paciuksenkatu 29, 6th Floor
Helsinki,  FI 00270
Applicant Contact Kalpana Jha
Correspondent
Mvision AI OY
Paciuksenkatu 29, 6th Floor
Helsinki,  FI 00270
Correspondent Contact Kalpana Jha
Regulation Number892.2050
Classification Product Code
QKB  
Date Received05/24/2024
Decision Date 10/18/2024
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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