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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 K192973
Device Name densitas densityai
Densitas, Inc.
#66, 1344 Summer Street
Halifax,  CA B3H0A8
Applicant Contact Mo Abdolell
Densitas Inc.
#66, 1344 Summer Street
Halifax,  CA B3H0A8
Correspondent Contact Alex Morris
Regulation Number892.2050
Classification Product Code
Date Received10/24/2019
Decision Date 02/19/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No