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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 K230264
Device Name Ezra Flash
Applicant
Ezra AI, Inc.
419 Park Ave S, Suite 600
New York,  NY  10016
Applicant Contact David Girard
Correspondent
Ezra AI, Inc.
419 Park Ave S, Suite 600
New York,  NY  10016
Correspondent Contact David Girard
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/31/2023
Decision Date 04/13/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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