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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 K213976
Device Name Contour ProtégéAI
Applicant
MIM Software Inc.
25800 Science Park Drive – Suite 180
Cleveland,  OH  44122
Applicant Contact Lynn Hanigan
Correspondent
MIM Software Inc.
25800 Science Park Drive – Suite 180
Cleveland,  OH  44122
Correspondent Contact Lynn Hanigan
Regulation Number892.2050
Classification Product Code
QKB  
Date Received12/20/2021
Decision Date 02/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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