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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 K203578
Device Name OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
Perimeter Medical Imaging AI, Inc.
359 Eastern Avenue, Suite 110
Toronto,  CA M4M 1B7
Applicant Contact Elizabeth Munro
Domecus Consulting Services, LLC
1171 Barroihet Avenue,
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number892.1560
Classification Product Code
Date Received12/07/2020
Decision Date 02/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No