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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K200990
Device Name VIDAvision
Applicant
VIDA Diagnostics Inc.
2500 Crosspark Rd, W250 BioVentures Center
Coralville,  IA  52241
Applicant Contact Sandra Stapleton
Correspondent
VIDA Diagnostics Inc.
2500 Crosspark Rd, W250 BioVentures Center
Coralville,  IA  52241
Correspondent Contact Alex Morris
Regulation Number892.1750
Classification Product Code
JAK  
Date Received04/15/2020
Decision Date 08/07/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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