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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 K240554
Device Name InferRead Lung CT.AI
Applicant
Infervision Medical Technology Co., Ltd.
Rm. B401, 4th Floor, Bldg. 1, #12 Shangdi
Information Rd., Haidian District
Beijing,  CN
Applicant Contact Matt Deng
Correspondent
Infervision Medical Technology Co., Ltd.
Rm. B401, 4th Floor, Bldg. 1, #12 Shangdi
Information Rd., Haidian District
Beijing,  CN
Correspondent Contact Matt Deng
Regulation Number892.2050
Classification Product Code
OEB  
Subsequent Product Code
QIH  
Date Received02/28/2024
Decision Date 05/16/2025
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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