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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 K193252
Device Name Contour ProtegeAI
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 Received11/25/2019
Decision Date 07/02/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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