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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K210916
Device Name PVmed Contouring Software
Applicant
Perception Vision Medical Technologies Ltd.Co.
Rm. 306, First Phase Office Bldg., # 12
Yuyan Rd., Huangpu District
Guangzhou,  CN 510530
Applicant Contact Chuanji Huang
Correspondent
Perception Vision Medical Technologies Ltd.Co.
Rm. 306, First Phase Office Bldg., # 12
Yuyan Rd., Huangpu District
Guangzhou,  CN 510530
Correspondent Contact Chuanji Huang
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/29/2021
Decision Date 12/03/2021
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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