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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
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