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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K220910
Device Name Medical image processing software
Applicant
Hangzhou Deepwise & League of PHD Technology Co., Ltd.
Rm. 705, Bldg. 8, 1818-2 Wenyi W. Rd.,
Yuhang District
Hangzhou,  CN 311121
Applicant Contact Hailong Xu
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui
#5, Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/29/2022
Decision Date 08/11/2022
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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