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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 K183320
Device Name Ilumien Optis, Optis Integrated, Optis Mobile
Applicant
St. Jude Medical (now Abbott Medical)
One St. Jude Medical Drive
St. Paul,  MN  55117
Applicant Contact Steve Vitale
Correspondent
St. Jude Medical (now Abbott Medical)
One St. Jude Medical Drive
St. Paul,  MN  55117
Correspondent Contact Steve Vitale
Regulation Number892.1560
Classification Product Code
NQQ  
Subsequent Product Code
IYO  
Date Received11/30/2018
Decision Date 04/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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