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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
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