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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, Image Processing, Radiological
510(k) Number K220649
Device Name Elucis
Applicant
Realize Medical Inc.
405-2197 Riverside Drive
Ottawa,  CA K1H 7X3
Applicant Contact Dan La Russa
Correspondent
Realize Medical Inc.
405-2197 Riverside Drive
Ottawa,  CA K1H 7X3
Correspondent Contact Dan La Russa
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/07/2022
Decision Date 01/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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