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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
Applicant
Abbott Medical
4 Robbins Rd.
Westford,  MA  01886
Applicant Contact Derek Pike
Correspondent
Abbott Medical
4 Robbins Rd.
Westford,  MA  01886
Correspondent Contact Derek Pike
Regulation Number892.1560
Classification Product Code
NQQ  
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
Predetermined Change
Control Plan Authorized		 No
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