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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 K250337
Device Name AiORTA - Plan
Applicant
ViTAA Medical Solutions, Inc.
2590 Rue De Rouen
Montreal,  CA H2K1M6
Applicant Contact Mitchel Benovoy
Correspondent
Bml Health, Inc.
626 Rue De La Congregation
Montreal,  CA H3K2J2
Correspondent Contact Marc Saab
Regulation Number892.2050
Classification Product Code
QIH  
Date Received02/06/2025
Decision Date 10/30/2025
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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