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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K250237
Device Name InferOperate Suite
Applicant
Beijing Infervision Healthcare Medical Technology Co., Ltd.
Rm. B403, 4th Floor, Bldg. 1, #12, Shangdi Information
Haidian District
Beijing,  CN 100085
Applicant Contact Matt Deng
Correspondent
Beijing Infervision Healthcare Medical Technology Co., Ltd.
Rm. B403, 4th Floor, Bldg. 1, #12, Shangdi Information
Haidian District
Beijing,  CN 100085
Correspondent Contact Matt Deng
Regulation Number892.2050
Classification Product Code
QIH  
Date Received01/27/2025
Decision Date 09/15/2025
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		 Yes
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