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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 K203235
Device Name VBrain
Applicant
Vysioneer Inc.
33 Rogers. St., # 308
Cambridge,  MA  02142
Applicant Contact Jen-Tang Lu
Correspondent
Vysioneer Inc.
33 Rogers. St., # 308
Cambridge,  MA  02142
Correspondent Contact Chiu S Lin
Regulation Number892.2050
Classification Product Code
QKB  
Date Received11/03/2020
Decision Date 03/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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