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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 K210458
Device Name OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
Applicant
Abbott Medical
4 Robbins Road
Westford,  MA  01886
Applicant Contact Steve Vitale
Correspondent
Abbott Medical
4 Robbins Road
Westford,  MA  01886
Correspondent Contact Steve Vitale
Regulation Number892.1560
Classification Product Code
NQQ  
Subsequent Product Codes
DQK   DSK  
Date Received02/16/2021
Decision Date 06/08/2021
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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