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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, imaging, optical coherence tomography (oct)
510(k) Number K232386
Device Name ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6
Abbott Medical
4 Robbins Road
Westford,  MA  01886
Applicant Contact Derek Pike
Abbott Medical
4 Robbins Road
Westford,  MA  01886
Correspondent Contact Derek Pike
Regulation Number892.1560
Classification Product Code
Date Received08/09/2023
Decision Date 09/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No