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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K252103
Device Name Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
Applicant
Mighty Oak Medical
750 W. Hampden Ave.
Suite 120
Englewood,  CO  80110
Applicant Contact Mark Wylie
Correspondent
Mighty Oak Medical
750 W. Hampden Ave.
Suite 120
Englewood,  CO  80110
Correspondent Contact Mark Wylie
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received07/03/2025
Decision Date 12/02/2025
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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