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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 K261531
Device Name PV-iCurve Pro
Applicant
Perception Vision Medical Technology Co., Ltd.
Rm. 1305, 1306, 1307, 1311, Block B, Zhongda Science And Tec
Bldg. 705, W. District, Yard Garden, # 135, Xingang W. Rd.,
Guangzhou,  CN
Applicant Contact Xuling Lu
Correspondent
Perception Vision Medical Technology Co., Ltd.
Rm. 1305, 1306, 1307, 1311, Block B, Zhongda Science And Tec
Bldg. 705, W. District, Yard Garden, # 135, Xingang W. Rd.,
Guangzhou,  CN
Correspondent Contact Xuling Lu
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/08/2026
Decision Date 10/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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