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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
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