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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radiological computer-assisted triage and notification software
510(k) Number K211179
Device Name InferRead CT Stroke.AI
Infervision Medical Technology Co., Ltd.
Room B401, 4th Floor, Building 1,
No. 12 Shangdi Information Road, Haidian District
Beijing,  CN 100085
Applicant Contact Xiaoyan Fan
Infervision US Inc
1900 Market St
Philadelphia,  PA  19103
Correspondent Contact Matt Deng
Regulation Number892.2080
Classification Product Code
Date Received04/20/2021
Decision Date 08/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No