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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 K200323
Device Name AutoContour
Applicant
Radformation, Inc.
335 Madison Avenue, 16th floor
New York,  NY  10017
Applicant Contact Kurt Sysock
Correspondent
Radformation, Inc.
335 Madison Avenue, 16th floor
New York,  NY  10017
Correspondent Contact Kurt Sysock
Regulation Number892.2050
Classification Product Code
QKB  
Date Received02/10/2020
Decision Date 10/30/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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