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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Image Processing Software For Radiation Therapy
510(k) Number K242925
Device Name MR Contour DL
Applicant
Ge Healthcare
500 W. Monroe St.
Chicago,  IL  60661
Applicant Contact Allena Holzworth
Correspondent
Ge Healthcare
500 W. Monroe St.
Chicago,  IL  60661
Correspondent Contact Allena Holzworth
Regulation Number892.2050
Classification Product Code
QKB  
Date Received09/24/2024
Decision Date 04/01/2025
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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