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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
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