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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 K253818
Device Name Annalise Enterprise
Applicant
Harrison-AI Medical Pty, Ltd.
24 Campbell St.
Level P
Sydney,  AU 2000
Applicant Contact Haylee Bosshard
Correspondent
Harrison-AI Medical Pty Ltd (formerly Annalise-AI Pty Ltd)
24 Campbell St.
Level P
Sydney,  AU 2000
Correspondent Contact Haylee Bosshard
Regulation Number892.2080
Classification Product Code
QAS  
Date Received11/28/2025
Decision Date 03/03/2026
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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