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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K251004
Device Name Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
Applicant
Hefei Chimed Intelligent Machine Co., Ltd.
Entire Bldg. 1 #B, Innovation And Entrepreneurship Park
Furong Rd.economic And Technological Development Zone
Hefei,  CN 230601
Applicant Contact Min Li
Correspondent
Grzan Medical Technology (Shenzhen) Co., Ltd.
Rm. 103-108, 1st Floor, Block B, Bldg. 2, Bangkai
Science And Technology Park, Guanguang Rd., Guangming Distr
Shenzhen,  CN 518107
Correspondent Contact Garen Liu
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Code
JAA  
Date Received04/01/2025
Decision Date 11/06/2025
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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