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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 K242729
Device Name AutoContour (Model RADAC V4)
Applicant
Radformation, Inc.
261 Madison Ave.
9th Floor
New York,  NY  10016
Applicant Contact Jennifer Wampler
Correspondent
Radformation, Inc.
261 Madison Ave.
9th Floor
New York,  NY  10016
Correspondent Contact Jennifer Wampler
Regulation Number892.2050
Classification Product Code
QKB  
Subsequent Product Code
QIH  
Date Received09/10/2024
Decision Date 12/09/2024
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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