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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Source, Brachytherapy, Radionuclide
510(k) Number K252296
Device Name OncoPatch
Applicant
Oncopatch, Inc.
12635 E Montview Blvd.
Aurora,  CO  80045
Applicant Contact Sam Murray
Correspondent
TAMM Net, Inc.
3101 Cobb Pkwy.
Atlanta,  GA  30339
Correspondent Contact Sam Murray
Regulation Number892.5730
Classification Product Code
KXK  
Date Received07/23/2025
Decision Date 12/05/2025
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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