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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 K233749
Device Name Revolution Ascend Sliding
Applicant
GE Hangwei Medical Systems Co., Ltd.
West Area of Building No 3, No.1 Yongchang North Road
Beijing Economic & Technological Develop,  CN 100176
Applicant Contact Wenqing Tian
Correspondent
GE Hangwei Medical Systems Co., Ltd.
West Area of Building No 3, No.1 Yongchang North Road
Beijing Economic & Technological Develop,  CN 100176
Correspondent Contact Haibo He
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/22/2023
Decision Date 02/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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