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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 K243057
Device Name TrueFit Bolus; TrueFlex Bolus
Applicant
Adaptiiv Medical Technologies, Inc.
1969 Upper Water Street, Suite 906
Halifax,  CA B3J 3R7
Applicant Contact Olga Zhuk
Correspondent
Adaptiiv Medical Technologies, Inc.
1969 Upper Water Street, Suite 906
Halifax,  CA B3J 3R7
Correspondent Contact Olga Zhuk
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received09/27/2024
Decision Date 10/23/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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