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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 K231767
Device Name Annalise Enterprise CTB Triage Trauma
Applicant
Annalise-AI Pty Ltd
Level P, 24 Campbell St
Sydney,  AU 2000
Applicant Contact Haylee Bosshard
Correspondent
Annalise-AI Pty Ltd
Level P, 24 Campbell St
Sydney,  AU 2000
Correspondent Contact Haylee Bosshard
Regulation Number892.2080
Classification Product Code
QAS  
Date Received06/16/2023
Decision Date 09/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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