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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 K260308
Device Name TrueFit Bolus
Applicant
Adaptiiv Medical Technologies, Inc.
1559 Barrington St., Suite 200-D
Halifax,  CA B3J 1Z8
Applicant Contact Olga Zhuk
Correspondent
Adaptiiv Medical Technologies, Inc.
1559 Barrington St., Suite 200-D
Halifax,  CA B3J 1Z8
Correspondent Contact Olga Zhuk
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received01/30/2026
Decision Date 02/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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