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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Medical Image
510(k) Number K223133
Device Name VisiRad XR
Applicant
Imidex Inc.
3513 Brighton Blvd., Suites 456 7 454
Denver,  CO  80216
Applicant Contact Kris Zeschin
Correspondent
Imidex Inc.
3513 Brighton Blvd., Suites 456 7 454
Denver,  CO  80216
Correspondent Contact Kris Zeschin
Regulation Number892.2070
Classification Product Code
MYN  
Date Received10/03/2022
Decision Date 08/03/2023
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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