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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 K230220
Device Name NeuViz 128 Multi-Slice CT Scanner System
Applicant
Neusoft Medical Systems Co., Ltd.
No. 177-1 Chuangxin Road, Hunnan District
Shenyang,  CN 110167
Applicant Contact Tian Yuehui
Correspondent
Neusoft Medical Systems Co., Ltd.
No. 177-1 Chuangxin Road, Hunnan District
Shenyang,  CN 110167
Correspondent Contact Tian Yuehui
Regulation Number892.1750
Classification Product Code
JAK  
Date Received01/26/2023
Decision Date 10/11/2023
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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