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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 K232928
Device Name DeepContour (V1.0)
Applicant
Wisdom Technologies., Inc.
4th Floor, Bldg. F2, Phase Ii, Innovation Industrial Park
Hefei,  CN 230088
Applicant Contact Xie George Xu
Correspondent
Wisdom Technologies., Inc.
11 Longstreet
Irvine,  CA  92620
Correspondent Contact Wang Wei
Regulation Number892.2050
Classification Product Code
QKB  
Date Received09/20/2023
Decision Date 05/07/2024
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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