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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lung Computed Tomography System, Computer-Aided Detection
510(k) Number K192880
Device Name InferRead Lung CT.AI
Applicant
Beijing Infervision Technology Co., Ltd.
Haidian District
Beijing,  CN 100085
Applicant Contact Xiaoyan Fan
Correspondent
Infervision Us, Inc.
1900 Market St.
8th Floor
Philadelphia,  PA  19103
Correspondent Contact Matt Deng
Regulation Number892.2050
Classification Product Code
OEB  
Subsequent Product Code
LLZ  
Date Received10/09/2019
Decision Date 07/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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