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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K250970
Device Name Marie
Applicant
Leo Cancer Care
7921 Uw Health Court
Middleton,  WI  53562
Applicant Contact Nickie Power
Correspondent
Leo Cancer Care
7921 Uw Health Court
Middleton,  WI  53562
Correspondent Contact Nickie Power
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/31/2025
Decision Date 07/25/2025
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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