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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 K192686
Device Name Revolution Maxima, Revolution Ace
Applicant
Ge Hangwei Medical Systems Co., Ltd.
West Area Of Bldg. #3, #1 Yongchang N. Rd.
Beijing Economic & Technological Develop,  CN 100176
Applicant Contact Haibo He
Correspondent
Ge Hangwei Medical Systems Co., Ltd.
West Area Of Bldg. #3, #1 Yongchang N. Rd.
Beijing Economic & Technological Develop,  CN 100176
Correspondent Contact Haibo He
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/26/2019
Decision Date 10/24/2019
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
Recalls CDRH Recalls
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