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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 K192956
Device Name Auto Positioning
Applicant
GE Hangwei Medical Systems, Co., Ltd.
West Area of Building No.3, No.1 Yongchang North Road
Beijing,  CN 100176
Applicant Contact Yonghui Han
Correspondent
GE Hangwei Medical Systems, Co., Ltd.
West Area of Building No.3, No.1 Yongchang North Road
Beijing,  CN 100176
Correspondent Contact Yonghui Han
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/21/2019
Decision Date 01/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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