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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K182643
Device Name IRIS 1.0 System
Intuitive Surgical
1266 Kifer Road
Sunnyvale,  CA  94086
Applicant Contact Crystal Ong
Intuitive Surgical
1266 Kifer Road
Sunnyvale,  CA  94086
Correspondent Contact Crystal Ong
Regulation Number892.2050
Classification Product Code
Date Received09/24/2018
Decision Date 02/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No