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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 K212116
Device Name VBrain-OAR
Applicant
Vysioneer Inc.
33 Rogers. St., # 308
Cambridge,  MA  02142
Applicant Contact Vicki Lin
Correspondent
Vysioneer Inc.
33 Rogers. St., # 308
Cambridge,  MA  02142
Correspondent Contact Vicki Lin
Regulation Number892.2050
Classification Product Code
QKB  
Date Received07/07/2021
Decision Date 10/12/2021
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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