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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 K171198
Device Name NeuViz 16 Essence Multi-slice CT Scanner System
Applicant
Neusoft Medical Systems Co., Ltd.
No. 16, Shiji Road
Hunnan Industrial Area
Shenyang,  CN 110179
Applicant Contact Shao Xiancheng
Correspondent
Neusoft Medical Systems Co., Ltd.
No. 16, Shiji Road
Hunnan Industrial Area
Shenyang,  CN 110179
Correspondent Contact Shao Xiancheng
Regulation Number892.1750
Classification Product Code
JAK  
Date Received04/24/2017
Decision Date 12/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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