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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 K254207
Device Name AiORTA - Plan v2.0
Applicant
ViTAA Medical Solutions, Inc.
2590 Rue De Rouen
Montreal,  CA H2K1M6
Applicant Contact Mitchel Benovoy
Correspondent
MCRA an IQVIA Business
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Kyle O'Sullivan
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/29/2025
Decision Date 03/30/2026
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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