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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
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