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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, planning, radiation therapy treatment
510(k) Number K213438
Device Name 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
1344 Summer Street
Suite 406
Halifax,  CA B3H 0A8
Applicant Contact Anastasiia Mereshchuk
1344 Summer Street
Suite 406
Halifax,  CA B3H 0A8
Correspondent Contact Anastasiia Mereshchuk
Regulation Number892.5050
Classification Product Code
Date Received10/22/2021
Decision Date 01/19/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No