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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 K260973
Device Name InferOperate Suite
Applicant
Beijing Infervision Healthcare Medical Technology Co., Ltd.
Rm. B403, 4th Floor, Bldg. 1, #12, Shangdi Information Rd.,
Beijing,  CN 100085
Applicant Contact Matt Deng
Correspondent
Beijing Infervision Healthcare Medical Technology Co., Ltd.
Rm. B403, 4th Floor, Bldg. 1, #12, Shangdi Information Rd.,
Beijing,  CN 100085
Correspondent Contact Matt Deng
Regulation Number892.2050
Classification Product Code
QIH  
Date Received03/24/2026
Decision Date 07/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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