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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 K251763
Device Name IRISeg
Applicant
Intuitive Surgical, Inc.
1266 Kifer Rd.
Suunyvale,  CA  94086
Applicant Contact Jyh-Shyan Lin
Correspondent
Intuitive Surgical, Inc.
1266 Kifer Rd.
Suunyvale,  CA  94086
Correspondent Contact Jyh-Shyan Lin
Regulation Number892.2050
Classification Product Code
QIH  
Subsequent Product Code
LLZ  
Date Received06/09/2025
Decision Date 12/16/2025
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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