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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 K253459
Device Name OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
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  
Subsequent Product Codes
DQK   DSK  
Date Received10/07/2025
Decision Date 04/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Cardiovascular
Type Traditional
Clinical Trials NCT04356027
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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