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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Triage And Notification Software
510(k) Number K260729
Device Name Vascular Assist Occlusion Triage (VAOT) (v1.0)
Applicant
GuideAI Health
45 Temple St., Unit 106
Boston,  MA  02114
Applicant Contact Raj Shah
Correspondent
Innolitics, LLC
1101 W. 34th St. #550
Austin,  TX  78705
Correspondent Contact J. David Giese
Regulation Number892.2080
Classification Product Code
QAS  
Date Received03/06/2026
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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