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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
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