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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K192969
Device Name Ezra Plexo Software
Applicant
Ezra Ai, Inc.
79 Madison Ave., Suite 545
New York,  NY  10016
Applicant Contact David Girard
Correspondent
Ezra Ai, Inc.
79 Madison Ave., Suite 545
New York,  NY  10016
Correspondent Contact David Girard
Regulation Number892.2050
Classification Product Code
QIH  
Date Received10/23/2019
Decision Date 07/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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